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Clinical Trials

Below are some research studies that are currently active across St. David’s HealthCare. Please continue to check back as additional trials are added to this list.

Protocol Contact Person Phone Status Research Area Study Number

Da Vinci surgical system data collection and analysis to improve surgeon efficiency and performance

Krishna Saini 512-544-8070 Pending Surgery 19-07-02

PASTIS- Preemptive Apnea Study and Therapy Impact on AF Substrate

Deb Cardinal 512-431-4868 Pending Cardiac Arrhythmia 19-07-03W

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3
Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for
Severe Cerebral Edema following Large Hemispheric Infarction- Protocol # 252LH301

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Krishsna Saini 512-544-8070 Pending Neurology 19-09-01

Novel Cardiac Signal Processing System for Electrophysiology Procedures (PURE EP 2.0 STUDY)

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Deb Cardinal 512-431-4868 Pending Cardiovascular 19-11-02XP

Biomarker profile in patients developing device thrombus post-LAA occlusion (PREDICT-CLOT)

Deb Cardinal 512-431-4868 Pending Cardiovascular 20-03-04

(ULTRA HFIB) Ultrasound-Based Renal Sympathetic Denervation As Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: A Pilot Study

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Deb Cardinal 512-431-4868 Pending Cardiovascular 20-04-06

The Rampart™ Duo Clinical (Radical Study)

Krishna Saini 512-544-8070 Open Spine 17-08-03

Rainbow Extension Study CRFB002H2301E1: an extension study to evaluate the long term efficacy and safety of RAnibizumab compared with laser therapy for the treatment of INfants BOrn prematurely With retinopathy of prematurity

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Margaret Rodriguez 512-451-0103 Open Neonatal Medicine 17-08-06W

Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision Total Knee Arthroplasty

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Jake Rabin 512-583-0217 Open Orthopedics 17-08-07W

Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Complex Primary Total Knee Arthroplasty

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Jake Rabin 512-583-0217 Open Orthopedics 17-08-08W

The Randomized And Controlled Noninferiority Trial to Evaluate the Safety and Clinical Efficacy of the SurVeil™ Drug-Coated Balloon in the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® Drug-Coated Balloon- TRANSCEND Study

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Mary Fraser 512-421-3841; 512-421-3827 Open Cardiovascular 17-09-02

A MULTI-CENTER, RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THE CARDIVA MID-BORE VENOUSO VASCULAR CLOSURE SYSTEM (VVCS) VS. MANUAL COMPRESSION FOR THE MANAGEMENT OF THE FEMORAL VENOTOMY AFTER CATHETER-BASED INTERVENTIONS PERFORMED VIA 6- 12 FR PROCEDURAL SHEATHS WITH SINGLE OR MULTIPLE ACCESS SITES PER LIMB

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Deb Cardinal 512-458-9410 Open Cardiovascular 17-09-03W

The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study

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Mary Fraser 512-341-2812, x. 2812 Open Cardiovascular 17-09-04

A Clinical Evaluation using EnSite Precision Cardiac Mapping System (software version 2.0.1 or higher) in a Real-World Environment

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 17-10-02W

Half-normal saline vs normal saline for irrigation of radiofrequency catheters in idiopathic left ventricular outflow tract ventricular arrhythmias ablation: SALINE PVC/VT

Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 17-10-03

Half-normal saline vs normal saline for irrigation of open-irrigated radiofrequency catheters in atrial fibrillation ablation – SALINE – AF

Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 17-10-04

A Randomized Controlled Clinical Evaluation of the DiamondTemp™ System for the Treatment of Paroxysmal Atrial Fibrillation

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Deb Cardinal 512-431-4868 Open Cardiovascular 17-10-08W

Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial

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Bonnie Punske, PhD 512-651-8406 Open Cardiovascular 17-11-03

ANCHOR: Aneurysm Treatment using the Aptus™ Heli-FX EndoAnchor System Global Registry

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Bonnie Punske, PhD 512-651-8406 Open Cardiovascular 17-11-04

CyberHeart’s cardiac arrhythmia ablation treatment: Patients with Refractory Ventricular Tachycardia/Fibrillation

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-01-02W

WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-01-03W

A Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study to assess the efficacy and safety of maribavir compared to valganciclovir for the treatment of cytomegalovirus (CMV) infection in hematopoietic stem cell transplant recipients

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Gabby Williams 615-524-4445 Open Oncology 18-01-06W

Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

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Mary Fraser 512-421-3841 Open Cardiovascular 18-02-02

TRYTON Post Approval Study (PAS)

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Mary Fraser 512-421-3841 Open Cardiovascular 18-03-01

XIENCE 90 Study

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Mary Fraser 512-421-3841 Open Cardiovascular 18-03-03

BMT 24-A Phase II Single Arm Study of Nivolumab as Maintenance Therapy after Autologous Stem Cell Transplantation in atients with Hodgkin Lymphoma at Risk of Relapse or Progression

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Renee Stojanovic 512-816-7399 Open Oncology 18-03-06W

Protection against Embolism for non-valvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology – PINNACLE FLX

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-03-09W

FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT (LESS-VT) Study

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-03-10W

Exploratory Study of Robot-aided Stroke Therapy with the Harmony Upper-body Exoskeleton

Ana Christine de Oliveira 512-293-9639 Open Rehabilitation 18-03-12W

ECG Belt for CRT Response

Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-04-03W

Prophylactic Antimicrobials after Cesarean Trial (PACT)

Caroline Gleason 512-493-6905 Open Maternal Fetal Medicine 18-05-02

PVAI plus scar homogenization and ablation of non-PV triggers ensure long-term recurrence-free survival in non-paroxysmalatrial fibrillation (TANTRA)

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-05-03

An International VT Ablation Center Collaborative Group (IVTCC): Multicenter Ventricular Tachycardia Catheter Ablation Registry

Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-05-04

Genetic Variation, Stress, and Functional Outcomes After Stroke Rehabilitation

Krishna Saini, MBBS 512-544-8070 Open Neurology 18-06-01

CANSCRIPT, CLINICAL OUTCOMES IN A REAL-WORLD SETTING (ANCERS)-2: A PROSPECTIVE, MULTICENTER, OBSERVATIONAL STUDY EXAMINING THE CLINICAL UTILITY OF CANSCRIPT TM IN ROUTINE CLINICAL PRACTICE

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Luisa Sansalone 512-354-6391 Open Oncology 18-06-02W

(CONNECT-HF)-CARE OPTIMIZATION THROUGH PATIENT AND HOSPITAL ENGAGEMENT CLINICAL TRIAL FOR HEART FAILURE

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Deb Cardinal 512-431-4868 Open Cardiovascular 18-06-04W

Postpartum management of hypertension in pregnancy with hydrochlorothiazide: a randomized clinical trial

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Caroline Gleason 512-493-6905 Open Maternal Fetal Medicine 18-07-04

Optical Coherence Tomography (OCT) Guided Coronary Stent Implantation Compared to Angiography: a Multicenter Randomized TriaL in PCI- ILUMIEN IV: OPTIMAL PCI

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Mary Fraser 512-421-3841 Open Cardiovascular 18-07-05

REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Covia Medical, nc. IASD® System II to REDUCE Elevated left Atrial Pressure in Patients with Heart Failure

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Deb Cardinal 512-431-4868 Open Cardiovascular 18-07-07W

Safety and Effectiveness Evaluation of Multi-electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-07-08W

Visitag Surpoint COA-Evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI) (SURPOINT COA)

Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-07-09W

Examination of glucocorticoid response in PBMCs from cord blood of infants exposed antenatally to synthetic glucocorticoids

Allison Brannen Open Neonatal Medicine 18-08-01

National Cardiogenic Shock Initiative

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Ruth Anne Sullivan 512-334-8973 Open Cardiovascular 18-09-01

REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure

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Mary Fraser 512-421-3841 Open Cardiovascular 18-09-02

A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects with Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study)

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Renee Stojanovic 512-816-7399 Open Oncology 18-09-04W

Safety and Effectiveness of TactCath™ Contact Force, Sensor Enabled™ (TactiCathSE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END Trial)

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-09-05W

WATCHMAN for Patients with Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement – WATCH-TAVR

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Mary Fraser 512-421-3841 Open Cardiovascular 18-10-01

ANEURYSM RESEARCH REGISTRY PROTOCOL

Krishna Saini 512-544-8070 Open Aneurysm 18-10-03

A Prospective Clinical Evaluation of the Diamond Temp™ System for the Treatment of Persistent Atrial Fibrillation

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-10-05W

Cross-Seal™ IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-Seal™ Suture-Mediated Vascular Closure Device System

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Bonnie Punske, PhD 512-651-8406 Open Surgery 18-11-02

Post-Approval Study of the R3 Biolox delta Ceramic Acetabular System – United States

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Krishna Saini 512-544-8070 Open Orthopedics 18-11-03

Correlation of supratherapeutic vancomycin trough levels with acute kidney injury (AKI) and other contributing factors in patients at an acute care hospital

Diantha Gonzales, PharmD Open Pharmacy 18-11-05X

Pre-pilot Study of Brain-Shift Monitoring Using 3D Scanning

Aaron Bernstein 512-750-6570 Open Surgery 18-11-06

Long-term Follow-up of Outcomes of the Convergent Procedure for the Treatment of Atrial Fibrillation

Bonnie Punske, PhD 512-651-8406 Open Cardiac Arrhythmia 18-12-01

A Phase 2 Multi-Center Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci Surgical System with Firefly Fluorescent Imaging

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Alwin Klaasen Open Surgery 18-12-02

Pulmonary Hypertension Registry

Allison Brannen 512-544-8174 Open Neonatal Medicine 18-12-03

Evaluation of QDOT MICRO™ catheter for pulmonary vein isolation (PVI) in subjects with Paroxysmal atrial Fibrillation (PAF)

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-12-04W

A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease

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Bonnie Punske, PhD 512-651-8406 Open Surgery 18-12-05W

Unpinning Termination Therapy for VT/VF

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 18-12-06W

A retrospective analysis on the use of Kcentra® in a community hospital setting

Neesha Thakkar Open Pharmacy 18-12-08X

Fixed dose prothrombin complex concentrate versus variable dosing for the emergent reversal of warfarin in a community hospital

Open Pharmacy 18-12-12X

GRAVITAS-309: A Phase 3 Study of Itcitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

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Renee Stojanovic 512-816-7399 Open Oncology 19-01-01W

A Learning Needs Assessment of Patients with Chronic Obstructive Pulmonary Disease (COPD)

Open Nursing 19-01-04X

Building a Repository of Cardiac Phase Signals for Algorithm Development Recruiting Mostly Female Subjects (CADFEM)

Mary Fraser 512-421-3841 Open Cardiovascular 19-01-05W

Cryo AF Global Registry

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 19-02-01W

Fetal Atrial Flutter & Supraventricular Tachycardia (FAST) Therapy Trial USA Study Protocols

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Jeannine Schuman-McCoy 512-901-1000 Open Maternal Fetal Medicine 19-03-01

National Cardiogenic Shock Initiative

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Mary Fraser 512-421-3841 Open Cardiovascular 19-03-02

Support after an event of severe maternal morbidity: A quality improvement project

Tonnyann Hurley 512-544-0115 Open Nursing 19-03-03X

Comparing Fatigue in Medical Transport Teams

Timothy Farmer 512-544-8190 Open Nursing 19-03-04X

Reducing 30-Day Unplanned Readmissions by Improving Self-efficacy for Mediation Adherence in TIA and Ischemic Stroke Patients and their Family Caregivers

Gloria Duke, PhD, RN 903-566-7023 Open Nursing 19-03-06W

A Randomized Trial of Pessary in Singleton Pregnancies with a Short Cervix

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Caroline Gleason 512-493-6905 Open Maternal Fetal Medicine 19-04-01

XIENCE 28 USA Study

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Mary Fraser 512-421-3841 Open Cardiovascular 19-04-03

Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation (START)

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Krishna Saini 512-544-8070 Open Neurology 19-04-05W

Improving Readmissions of Heart Failure Patients

Chrisettia Morgan 682-352-2984 Open Nursing 19-04-10X

Do Touchpoints Help Retain New Registered Nurses? One Healthcare System’s Experience

Lucy Koneri, RN, MSN 915-238-3332 Open Nursing 19-04-12X

A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination with Either Rituximab or Lenalidomide in Subjects with Refractory Large B-Cell Lymphoma (ZUMA-14)

Renee Stojanovic 512-816-7399 Open Oncology 19-04-13W

Clinical, Electrocardiographic, and Cardiac Magnetic Resonance Imaging Risk Factors Associated with Ventricular Tachyarrhythmias in Nonischemic Cardiomyopathy (MARVEN Study)

Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 19-05-01W

Repository of Phase Signals for Pulmonary Hypertension Algorithm Development (PHDEV)

Mary Fraser 512-421-3841 Open Radiology 19-05-04W

Low voltage-Directed Catheter Ablation for Atrial Fibrillation (LD-CAF)

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Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 19-05-05W*

Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer Patients: Does this Improve Patient Outcomes?

Lindsey Cossel 615-974-9353 Open Oncology 19-06-02W

SINGLE-ARM, OPEN-LABEL, MULTI-CENTRE, PHASE I/II STUDY EVALUATING THE SAFETY AND CLINICAL ACTIVITY OF AUTO3, A CAR T CELL TREATMENT TARGETING CD19 AND CD22 AND CONSOLIDATION WITH ANTI PD-1 ANTIBODY IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA

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Rob Gordon 303-621-6197 Open Oncology 19-07-04W

A Multicenter Phase Ib Trial for Patients with Advanced Hematologic Malignancies undergoing Allogeneic Hematopoietic Cell Transplantation with TregGraft, a T-cell-Depleted Graft with Additional Infusion of Conventional T cells and Regulatory T Cells

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Rob Gordon 303-621-6197 Open Oncology 19-08-02W

Blood Coagulation Response After Percutaneous Left Atrial Appendage Occlusion (CLOT Study)

Deb Cardinal 512-431-4868 Open Cardiac Arrhythmia 19-08-03

Activity in Women at Risk for Early Delivery (AWARE)

Caroline Gleason 512-493-6905 Open Maternal Fetal Medicine 19-08-05

A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix- PROSPECT

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Caroline Gleason 512-493-6905 Open Maternal Fetal Medicine 19-09-02

aMAZE Left Atrial Appendage+® Ligation with the Lariat Suture Delivery System As Adjunctive Therapy to Pulmonary Vein Isolation (PVI) For Persistent or Longstanding Persistent Atrial Fibrillation

Deb Cardinal 512-431-4868 Open Cardiovascular 19-09-03AW

The SAVAL Pivotal Trial: A Randomized Trial comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Agioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia

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Mary Fraser 512-421-3841 Open Cardiovascular 19-10-01

A multi-center prospective study to evaluate the safety and effectiveness of the VasQ external support for arteriovenous fistula

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Bonnie Punske, PhD 512-651-8406 Open Cardiovascular 19-10-03

Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)

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Mary Fraser 512-421-3841 Open Cardiovascular 19-10-04

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

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Bonnie Punske, PhD 512-651-8406 Open Cardiovascular 19-10-05

A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy
and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of
necrotizing enterocolitis – The Connection study

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Krishna Saini, MBBS 512-544-8070 Open Neonatal Medicine 19-10-06

Cross-Seal™ IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-Seal™ Suture-Mediated Vascular Closure Device System

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Mary Fraser 512-421-3841 Open Cardiovascular 19-10-07

Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation (OPTION)

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Deb Cardinal 512-431-4868 Open Cardiovascular 19-10-11W

Early Feasibility Study of the AccuCinch Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation- The CorCinch PMVI Study

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Mary Fraser 512-421-3841 Open Cardiovascular 19-11-01

DyeVert System Use for Contrast Monitoring and Minimization in At-Risk Patients Undergoing Angiography Procedures: A Real-World Registry

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Kari Wilhelmi 952-955-8235 Open Registry 19-11-04W

RANDOMIZED, CONTROLLED, MULTI-CENTER STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF INTRAVITREAL AFLIBERCEPT COMPARED TO LASER PHOTOCOAGULATION IN PATIENTS WITH RETINOPATHY OF PREMATURITY

Margaret Rodriguez 512-451-0103 Open Ophthalmology, Neonatal Medicine 19-11-05

Zimmer Echo- Prospective Clinical Trial Follow-Up of the Echo Bi-Metric Microplasty stem for Total Hip Arthroplasty H.CR.I.AM.16.6

Open 19-12-01A

A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Sfety and Efficacy of the Cordella Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patietns

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Mary Fraser 512-421-3841 Open Cardiovascular 19-12-02

Evaluation of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

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Bonnie Punske, PhD 512-651-8406 Open Cardiovascular 19-12-03

Prospective, Randomized, Multi-center Post-Market study of Anterior Advantage Surgical Approach in Total Hip Arthroplasty with and without the KINCISE Surgical Automated System

Jake Rabin 512-583-0217 Open Orthopedics 19-12-04W

Virtual Reality-Assisted Anxiety and Pain Reduction for Pre-OP and Post-Op Orthopedic Care: A Randomized Control Trial (VR-PPOP)

Krishna Saini 512-5448070 Open Orthopedics 19-12-05

ConforMIS 14-003- A Prospective Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System

Jake Rabin 512-583-0217 Open Orthopedics 19-12-06A

BIOTRONIK- A Prospective Multicenter Study to Confirm the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with up to Three De Novo or Restenotic Coronary Artery Lesion- VII (BIOFLOW-VII Study)

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Mary Fraser 512-421-3841 Open Cardiovascular 20-01-01

PROTECTED-TAVR: Stroke Protection with sentinal During Transcatheter Aortic Valve Replacement

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Mary Fraser 512-421-3841 Open Cardiovascular 20-01-02

A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD)- AIRFLOW-3

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Krishna Saini 512-544-8070 Open Respiratory Therapy 20-01-03

A SINGLE-ARM, OPEN-LABEL, PHASE 1 STUDY EVALUATING THE SAFETY, EFFICACY, AND CELLULAR KINETICS/PHARMACODYNAMICS OF ALLO-501, AN ANTI-CD19 ALLOGENEIC CAR T CELL THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL OR FOLLICULAR LYMPHOMA

Open Oncology 20-01-05W

Phase 1 Study of Escalating Single and Multiple Doses of Mana 312 (Multi Tumor-Associated Antigen T cells) Administered to Adult Subjects with Acute Myeloid Leukemia or Myelodysplastic Syndrome after Allogeneic Hematopoietic Stem Cell Transplant

Renee Stojanovic 512-816-6423 Open Oncology 20-01-06W

(BMT-29) A Pilot Study of INCB039110 (Itacitinib) for the Treatment of Steroid Refractory Chronic Graft-Versus-Host Disease (cGVHD)

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Renee Stojanovic 512-816-6423 Open Oncology 20-01-07W

(BMT-30) Graft-Versus-Tumor Augmentation with Nivolumab for High-Risk Patients with MDS and AML after Allogeneic Stem Cell Transplantation Using Post-Transplantation Cyclophosphamide

Renee Stojanovic 512-816-6423 Open Oncology 20-01-08W

A single-arm, open-label, phase 1/2 study evaluating the safety, efficacy and cellular kinetics/pharmacodynamics of ALLO-501a, an anti-CD19 allogeneic Car-T cell therapy in patients with relapsed/refractory large B-Cell lymphoma (LBCL)

Robert Gordon 512-816-7399 Open Oncology 20-01-09W

A single-arm, open-label, Phase 1 study of the safety, efficacy and Cellular Kinetics/Pharmacodynamics of ALLO-715 to evaluate an Anti-BCMA Allogeneic CAR-T Cell Therapy in subjects with Relapsed/Refractory Multiple Myeloma

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Robert Gordon 512-816-7399 Open Oncology 20-01-10W

A Phase II Study Assessing CPX-351 (Vyxeos) with Quizartinib for the Treatment of Relapsed or Refractory FLT3-ITD Mutation-Positive AML

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Robert Gordon 512-816-7399 Open Oncology 20-01-11W

First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillatin Treatment: the RAAFT-3 Trial

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Deb Cardinal 512-431-4868 Open Cardiovascular 20-02-01

Maternal Infant Nutrition Study (MINT)

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Sara Dube 512-471-0941 Open Maternal Fetal Medicine 20-02-04W

A Prospective, Multi-Center, Single-Arm, Real World Study Assessing the Clinical Use of the Caterpillar Arterial Embolization Device for Arterial Embolization in the Peripheral Vasculature (MONARCH)

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Bonnie Punske, PhD 512-651-8406 Open Cardiovascular 20-03-02

Impact of Exercise on Pulmonary Artery Pressure in Patients with Heart Failure Using an Ambulatory PA Pressure Monitor

Mary Fraser 512-421-3841 Open Cardiovascular 20-03-03

(AIS-A02) An open label study of ALPN-101 in Steroid-Refractory Acute Graft Versus Host Disease (AGVHD)- The BALANCE Study (BMT 39)

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Renee Stojanovic 512-816-6423 Open Oncology 20-03-09W

The Cardiva VASCADE MVP VVCS Same Day Discharge Registry

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Deb Cardinal 512-431-4868 Open Cardiovascular 20-04-10W

A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects with Acute, Complicated Type B Aortic Dissections

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Bonnie Punske, PhD 512-651-8406 Open Cardiovascular 20-02-02

Evaluation of the Safety and Efficacy of the OPTIMIZER II System with Active Fixation Leads in Subjects with Heart Failure Resulting from Systolic Dysfunction – F/X-HF-5

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Deb Cardinal 512-458-9410 Open Cardiac Arrhythmia 04-05-03

Product Surveillance Registry

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Deb Cardinal 512-458-9410 Open Cardiovascular 10-03-02

The Austin Brain Tumor Repository

Max Shpak 512-544-8077 Open Oncology 10-05-03

Continuum Metal Bearing System in Total Hip Arthroplasty, a multi-center, prospective, non-controlled post market surveillance study Zimmer, Inc.

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Jake Rabin 512-583-0217 Open Orthopedics 11-08-03

Arrhythmogenic Substrate Evaluation and Ablation in Brugada Syndrome

Deb Cardinal 512-458-9410 Open Cardiac Arrhythmia 12-07-03

Prospective Multicenter Open Label Study Examining the Mid- and Long-term Safety and Efficacy of the 3DKnee System with Vitamin E UHMWPE Tibial Inserts (3DKnee with e-plus Insert)

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Jake Rabin 512-583-0217 Open Orthopedics 12-09-03

Pulmonary Vein Reconnection after Pulmonary Vein Antrum Isolation at Different Power Settings Using Adenosine Provocation – ZODIAC

Deb Cardinal 512-458-9410 Open Cardiovascular 12-11-03

The Safety and effectiveness of the SAPIEN XT Transcatheter Heart Valve with NovaFlex and Ascendra associated delivery systems in Intermediate and High Risk for Aortic Valve Surgery and Patients Who Cannot Undergo Surgery – PARTNER II

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Mary Fraser 512-740-0631 Open Cardiovascular 12-12-05

Prophylactic Cervicothoracic Sympathectomy for Prevention of Ventricular Tachycardia (PREVENT VT Trial)

Deb Cardinal 512-458-9410 Open Cardiovascular 13-04-03

Mild cognitive impairment (MCI) in patients with atrial fibrillation (AF), trajectories of the progression of MCI and factors associated with the progression – COGNITION

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Deb Cardinal 512-458-9410 Open Cardiovascular 13-05-01

A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries (Lutonix BTK Trial) Protocol # CL0005-01

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Mary Fraser 512-740-0631 Open Cardiovascular 13-06-02

Post Market Clinical Follow-Up Study of the Zimmer Vivacit-E Highly Crosslinked Polyethylene Liner used with the Continuum Acetabular Shell

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Jake Rabin 512-583-0217 Open Orthopedics 13-08-01

CONVERGE – Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF

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Mary Fraser 512-740-0631 Open Cardiovascular 13-10-02

Portico Re-Sheathable Transcatheter Aortic Valve System

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Mary Fraser 512-740-0631 Open Cardiovascular 14-01-04

Short, Medium and Long Term Survivorship of Attune Primary Total Knee Prosthesis DePuy Orthopaedics

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Jake Rabin 512-583-0217 Open Orthopedics 14-01-05

Evaluation of ACUITY X4 Quadripolar Coronary Venous Leads and Conditional Approved RELIANCE 4-FRONT Defibrillation Leads – NAVIGATE X4 Boston Scientific

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Deb Cardinal 512-458-9410 Open Cardiac Arrhythmia 14-04-02

Evaluation of ACUITY X4 Quadripolar Coronary Venous Leads and Conditional Approved RELIANCE 4-FRONT Defibrillation Leads – NAVIGATE X4 Boston Scientific

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Mary Fraser 512-458-9410 Open Cardiac Arrhythmia 14-05-01

Impact of life-Style modification On abLATion outcomE in atrial fibrillation (ISOLATE) – Lifestyle and AF

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Deb Cardinal 512-458-9410 Open Cardiac Arrhythmia 14-06-04

AdaptResponse Study

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Deb Cardinal 512-458-9410 Open Cardiac Arrhythmia 14-07-01

Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial (PERIGON)

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Bonnie Punske, PhD 512-651-8406 Open Cardiovascular 14-12-02

Endurant Evo US Clinical Trial

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Bonnie Punske, PhD 512-651-8406 Open Cardiovascular 15-04-03

MIMICS-2: The Evaluation of Safety and Efficacy of the BioMimcs 3D Nitinol Stent System in the Femoropopliteal Arteries of Patients with Symptomatic Peripheral Artery Disease

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Mary Fraser 512-740-0631 Open Cardiovascular 15-06-02

aMAZE TRIAL Left Atrial Appendage Ligation with the LARIAT® Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation (PVI) for Persistent or Longstanding Persistent Atrial Fibrillation

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Mary Fraser 512-740-0631 Open Cardiac Arrhythmia 15-08-01

AWARE: Impact of Anxiety on Cardiac Substrate Modification in Women wth Atrial Fibrillation Undergoing Catheter Ablation

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Deb Cardinal 512-458-9410 Open Cardiac Arrhythmia 15-08-04

The Endologix LEOPARD Study: A Multicenter, Prospective, Randomized, Post-Market, Real-World Study to Assess Outcomes of Patients Treated with the AFX® System Compared to other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair

Bonnie Punske, PhD 512-651-8406 Open Cardiovascular 15-09-01

A prospective, multi-center, post market randomized controlled trial comparing VT ablation outcomes using remote MAGNETIC Navigation guided substrate mapping and ablation versus manual approach in a low LVEF population – MAGNETIC VT

Deb Cardinal 512-458-9410 Open Cardiovascular 15-12-02

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients who have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
PARTNER 3 Protocol No. 2015-08

Mary Fraser 512-740-0631 Open Cardiovascular 16-02-04

The BARD® VENOVO ™ Venous Stent Study – A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease – an Assessment for Effectiveness and Safety (VERNACULAR) Protocol BPV-14-007

Bonnie Punske, PhD 512-651-8406 Open Cardiovascular 16-04-04

Genetics of Heritable Arrythmyia (Heritable Arrhythmia Genetics: HERITAGE)

Deb Cardinal 512-458-9410 Open Cardiac Arrhythmia 17-02-01 (10-2017-02)

Pharmaco-surveillance of oral anticoagulant therapies (OAT) and outcomes

Krishna Saini 512-544-8070 Open Pharmacy 17-03-02 (10-2017-07)

EMpagliflozin evaluation By measuRing ImpAct on HemodynamiCs in Patients with DiabEtes and Heart Failure (EMBRACE-HF)

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Mary Fraser 512-421-3841 Open Cardiovascular 17-03-04 (17-2017-05)

Randomized Control Trial: Physical Exam Indicated Cerlage in Twin Gestations (TWIN-PEIC)

Caroline Gleason 512-493-6905 Open Maternal Fetal Medicine 17-03-06W (14-2017-08W)

A multi-center, prospective, randomized study comparing surgical and economic parameters of Total Knee Replacement performed with single-use Efficiency instruments with patient-specific technique (MyKnee®) versus traditional metal instruments with conventional surgical technique

Tyler Goldberg, MD Open Orthopedics 17-05-01W

CarboClear Pedicle Screw System IDE Study

Carl Lauryssen, MD Open Spine 17-05-02W

TREAT: Treatment of ppROM with Erythromycin vs. Azithromycin Trial

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Caroline Gleason 512-493-6905 Open Maternal Fetal Medicine 17-06-01

Medtronic Attain Stability Quad Study

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Deb Cardinal 512-458-9410 Open Cardiac Arrhythmia 17-06-02W

Patient Outcomes with Early vs Delayed Ambulation Following Primary Total Hip Arthroplasty “Early Ambulation Study”

Andrea Torres 512-439-1117 Open Orthopedics 17-07-02

160326: A Multicenter, Open Label, Cross-Over Study to Assess the Pharmacokinetics and Safety of Diazepam Buccal Soluble Film (DBSF) in Adult Subjects with Epilepsy

Sami Aboumatar, MD Open Neurology 17-07-04W

A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS System

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Krishna Saini 512-544-8070 Closed Spine 17-08-02

Clinical Evaluation of the PartoSure™ Test

Richard Todd Hale, PhD o. 512-493-6927, c. 512-788-8980 Closed Maternal Fetal Medicine 17-09-01

Phoenix Exoskeleton for SCI Users

Robert Rambusek 512-544-8480 Closed Rehabilitation 17-12-02

TactiSense IDE SJM-CIP-10216

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Deb Cardinal 512-431-4868 Closed Cardiac Arrhythmia 18-01-04W

Patent Ductus Arteriosus Post NICU Discharge in Premature Infants: a Prospective Registry

Anthony Rudine, MD Closed Neonatal Medicine 18-02-03

A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 MM Everolumus-Eluting Platinum Chromium Coronary stent System (SYNERGY Stent System) for the Treatment of Subjects with Atherosclerotic Lesions – EVOLVE 48

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Mary Fraser 512-421-3841 Closed Cardiovascular 18-03-02

Cervical cerclage for preventing spontaneous preterm birth in twin pregnancies with short transvaginal ultrasound cervical length ≤ 15 mm: a study protocol for a randomized clinical trial

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Caroline Gleason 512-493-6905 Closed Maternal Fetal Medicine 18-07-01

Collection of samples from pregnant women for the evaluation of preeclampsia (pre-e) biomarkers

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Caroline Gleason 512-439-6905 Closed Maternal Fetal Medicine 18-11-04W

A Clinical Trial Investigating the efficacy of Patients Undergoing a Single Anastomosis Duodeno-Ileal Bypass in comparison with Laproscopic RNY Gastric Bypass and Laproscopic Sleeve Gastrectomy in regards to weight loss, maintenance of weight loss and reduction or resolution of weight related medical comorbidities

Allison Arnett 512-544-8163 Closed Bariatrics 19-03-05

Clinical Investigation of NanoFuse® Bioactive Matrix and Autogenous Bone in Spinal Fusion

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Krishna Saini 512-544-8070 Closed Spine 19-07-01

Impact of the Pulmonary Vein Isolation on Exercise Capacity in Patients with Chronic Atrial Fibrillation

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Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 08-11-09

QuickFlex 1258T – Left Heart Pacing Lead Post Approval Study

Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 10-11-04

Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients with Atrial Fibrillation Versus Long Term Warfarin Therapy – PREVAIL

Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 10-12-01

Ranolazine ICD Trial (RAID)

Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 11-04-01

The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Astron Pulsar Stents BIOFLEX-1

Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 11-05-01

A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy™ Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries – LEVANT 2

Mary Fraser 512-740-0631 Closed Cardiac Arrhythmia 11-06-01

Evaluation of XIENCE PRIME or XIENCE V versus Coronary Artery Bypass Graft Surgery for Effectiveness of Left Main Revasculartization – EXCEL

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Mary Fraser 512 740 0631 Closed Cardiovascular 11-09-03

Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System – Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation

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Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 11-11-04

Renal Denervation in Patients with Uncontrolled Hypertension SYMPLICITY HTN-3

Mary Fraser 512-740-0631 Closed Cardiovascular 11-11-05

Accent MRI Pacemaker and Tendril MRI Lead IDE Study

Mary Fraser 512-740-0631 Closed Cardiac Arrhythmia 12-05-01

A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Stent Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atheroschlerotic Lesion(s) (EVOLVE II)

Mary Fraser 512-740-0631 Closed Cardiovascular 12-08-02

Continued Access to PREVAIL (CAP2)

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Deb Cardinal 512-458-9410 Closed Cardiovascular 12-09-05

Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation – ZERO AF

Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 12-10-01

INGEVITY Active Fixation and Passive Fixation Pace/Sense Lead Study

Mary Fraser 512-740-0631 Closed Cardiac Arrhythmia 12-12-01

Cross-Sectional, Multi-Center Evaluation of 8 Year Metal Ion Trends for a Pinnacle MoM System Used in Primary Total Hip Arthroplasty

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Jake Rabin 512-583-0217 Closed Orthopedics 13-02-01

ImageReady MR Conditional Pacing System SAMURAI Clinical Study

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Deb Cardinal 512-458-9410 Closed Cardiovascular 13-03-01

Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients with a Myocardial Infarction and Ischemic Left Ventricular Dysfunction (ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration, ALLSTAR)

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Mary Fraser 512-740-0631 Closed Cardiovascular 13-12-02

Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)

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Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 14-07-02

Determining the association of chromosomal variants with non-PV triggers and ablation-outcome in AF-DECAF II

Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 14-09-01

Prospective, Single Arm Multiconfiguration Investigation to Assess the Functional Performance of Attune Primary Knee Arthroplasty System

Jake Rabin 512-583-0217 Closed Orthopedics 14-10-01

Patient-centered Research into Outcomes Stroke patients Prefer and Effectiveness Research (PROSPER)

Krishna Saini 512-544-8070 Closed Rehabilitation 14-11-01

TactiCath Contact Force Ablation Center Study for Atrial Fibrillation Post Approval Study

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Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 14-11-02

CardioMEMS HF System Post Approval Study

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Mary Fraser 512-740-0631 Closed Cardiovascular 14-11-05

LIBERTY 360 degrees: Prospective, Observational, Multi-Center Clinical Study to Evaluate Acute and Long Term Clinical and Economic Outcomes of Endovascular Device Intervention in Patients with Distal Outflow Peripheral Arterial Disease (PAD)

Bonnie Punske, PhD 512-651-8406 Closed Cardiovascular 15-01-01

SNP-based microdeletion and aneuploidy registry (SMART)

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Caroline Gleason 512-493-6905; c- 210-683-9335 Closed Maternal Fetal Medicine 15-04-01

Multicenter, Double-Blind, Placebo-Controlled Study of Vonapanitase (PRT-201) Administered Immediately after Radiocephalic Arteriovenous Fistula Creation in Patients with Chronic Kidney Disease

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Bonnie Punske, PhD 512-651-8406 Closed Nephrology 15-07-02

Anthropometric Data Collection of the Bariatric Population Hill-Rom

John Archibeque, MSN Closed Bariatrics 15-07-03

Bipolar Catheter Ablation for the Treatment of Refractory Scar-Related Ventricular Arrhythmia

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Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 15-08-03

SALUS – The Direct Flow Medical® Transcatheter Aortic Valve
Replacement System Pivotal Trial.
Protocol #IP011

Mary Fraser 512-740-0631 Closed Cardiovascular 15-08-06

ILUMIEN III: OPTIMIZER PCI: Optical Coherence Tomography (OCT) Compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter Randomized Trial in PCI

Mary Fraser 512-740-0631 Closed Cardiovascular 15-10-01

REGISTRY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS with SIGNIFICANT CAROTID ARTERY DISEASE
The ROADSTER 2 Registry

Bonnie Punske, PhD 512-651-8406 Closed Cardiovascular 15-10-02

Management of Acute Stroke Patients on Treatment with new Oral Anticoagulants: Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) Registry

Krishna Saini 512-544-8070 Closed Neurology 15-10-03

To Demonstrate the Safety and Effectiveness of the SurgWerksTM-CLI Kit and VXPTM System for the Rapid Intra-operative Aspiration, Preparation and Intramuscular Injection of Concentrated Autologous Bone Marrow Cells into the Ischemic Index Limb of Rutherford Category 5 Non-Reconstructable Critical Limb Ischemia Patients
CLIRST III
Protocol # CST/CLI/143003

Mary Fraser 512-740-0631 Closed Cardiovascular 15-12-03

Assessment of the utility of the Siemens P6 volume ICE catheter
in electrophysiology and structural heart disease procedures

Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 16-02-01

EVOLVE Short DAPT Study (S2073)
A prospective, multicenter, single-arm study designed to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with a SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)

Mary Fraser 512-740-0631 Closed Cardiovascular 16-02-02

RAINBOW study; a randomized, controlled study evaluating the efficacy and safety of ranibizumab comoared with laser therapy for the treatment of infants born prematurely with retinopathy of prematurity

Margaret Rodriguez 512-451-0103 Closed Neonatal Medicine 16-04-01

Patient Outcomes with Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block after Primary Total Knee Arthroplasty

Andrea Torres 972-849-1198 Closed Orthopedics 16-04-02

Early Results of 900 Consecutive, Anterior Approach Total Hip Arthroplasties

Andrea Torres 972-849-1198 Closed Orthopedics 16-04-03

MULTIPOINT PACING POST MARKET STUDY (MPP PMS)

Mary Fraser 512-740-0631 Closed Cardiac Arrhythmia 16-08-01

The PARTNER 3 Aortic Valve-in-Valve Trial: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve

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Mary Fraser 512-421-3841 Closed Cardiovascular 17-02-02 (17-2017-01)

Catheter Ablation of Arrhythmias to Improve CRT Response: The ABLATE-CRT Study

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Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 17-03-01 (10-2017-03)

EFFECTS OF DAPAGLIFLOZIN ON BIOMARKERS, SYMPTOMS AND FUNCTIONAL STATUS IN ATIENTS WITH TYPE 2 DIABETES OR PRE-DIABETES, AND PRESERVED EJECTION FRACTION HEART FAILURE (PRESERVED-HF TRIAL)

Mary Fraser 512-421-3841 Closed Cardiovascular 17-03-03 (17-2017-04)

Safety and Efficacy of Periprocedural Apixaban Use for Reduction of th eRisk of Cerebrovascular Evets in Patients Undergoing Ventricular Tachycardia Radiofrequency Catheter Ablation (STROKE-VT)

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Deb Cardinal 512-458-9410 Closed Cardiac Arrhythmia 17-04-01

Treatment for ppROM with Erythromycin vs. Azithromycin Trial

Caroline Gleason 512-493-6905 Closed Maternal Fetal Medicine 17-04-03W *

BMT 25 – TV44688-ONC-30054: A Single-Arm Study of the Effect of a 5-day Regimen of Tbo-Filgrastim 10 ìg/kg of Body Weight Administered Subcutaneously on Peripheral Stem Cell Mobilization in Healthy Donors

Brittany White 615-524-4149 Closed Oncology 17-07-03W

Long Term Follow-Up Study of ROADSTER 2 Patients

Bonnie Punske, PhD 512-651-8406 Closed Cardiovascular 17-08-01