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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.

ProtocolContact PersonPhoneStatusResearch AreaStudy Number

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

Krishna Saini512-544-8070PendingSurgery19-07-02

PASTIS- Preemptive Apnea Study and Therapy Impact on AF Substrate

Deb Cardinal512-431-4868PendingCardiac Arrhythmia19-07-03W

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 Saini512-544-8070PendingNeurology19-09-01

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

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Deb Cardinal512-431-4868PendingCardiovascular19-11-02XP

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

Deb Cardinal512-431-4868PendingCardiovascular20-03-04

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

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Deb Cardinal512-431-4868PendingCardiovascular20-04-06

The Rampart™ Duo Clinical (Radical Study)

Krishna Saini512-544-8070OpenSpine17-08-03

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 Rodriguez512-451-0103OpenNeonatal Medicine17-08-06W

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

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Jake Rabin512-583-0217OpenOrthopedics17-08-07W

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

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Jake Rabin512-583-0217OpenOrthopedics17-08-08W

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 Fraser512-421-3841; 512-421-3827OpenCardiovascular17-09-02

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 Cardinal512-458-9410OpenCardiovascular17-09-03W

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 Fraser512-341-2812, x. 2812OpenCardiovascular17-09-04

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 Cardinal512-431-4868OpenCardiac Arrhythmia17-10-02W

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

Deb Cardinal512-431-4868OpenCardiac Arrhythmia17-10-03

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

Deb Cardinal512-431-4868OpenCardiac Arrhythmia17-10-04

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

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Deb Cardinal512-431-4868OpenCardiovascular17-10-08W

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, PhD512-651-8406OpenCardiovascular17-11-03

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

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Bonnie Punske, PhD512-651-8406OpenCardiovascular17-11-04

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

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Deb Cardinal512-431-4868OpenCardiac Arrhythmia18-01-02W

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

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Deb Cardinal512-431-4868OpenCardiac Arrhythmia18-01-03W

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 Williams615-524-4445OpenOncology18-01-06W

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

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Mary Fraser512-421-3841OpenCardiovascular18-02-02

TRYTON Post Approval Study (PAS)

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Mary Fraser512-421-3841OpenCardiovascular18-03-01

XIENCE 90 Study

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Mary Fraser512-421-3841OpenCardiovascular18-03-03

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 Stojanovic512-816-7399OpenOncology18-03-06W

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 Cardinal512-431-4868OpenCardiac Arrhythmia18-03-09W

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

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Deb Cardinal512-431-4868OpenCardiac Arrhythmia18-03-10W

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

Ana Christine de Oliveira512-293-9639OpenRehabilitation18-03-12W

ECG Belt for CRT Response

Deb Cardinal512-431-4868OpenCardiac Arrhythmia18-04-03W

Prophylactic Antimicrobials after Cesarean Trial (PACT)

Caroline Gleason512-493-6905OpenMaternal Fetal Medicine18-05-02

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 Cardinal512-431-4868OpenCardiac Arrhythmia18-05-03

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

Deb Cardinal512-431-4868OpenCardiac Arrhythmia18-05-04

Genetic Variation, Stress, and Functional Outcomes After Stroke Rehabilitation

Krishna Saini, MBBS512-544-8070OpenNeurology18-06-01

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 Sansalone512-354-6391OpenOncology18-06-02W

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

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Deb Cardinal512-431-4868OpenCardiovascular18-06-04W

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

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Caroline Gleason512-493-6905OpenMaternal Fetal Medicine18-07-04

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 Fraser512-421-3841OpenCardiovascular18-07-05

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 Cardinal512-431-4868OpenCardiovascular18-07-07W

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

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Deb Cardinal512-431-4868OpenCardiac Arrhythmia18-07-08W

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 Cardinal512-431-4868OpenCardiac Arrhythmia18-07-09W

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

Allison BrannenOpenNeonatal Medicine18-08-01

National Cardiogenic Shock Initiative

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Ruth Anne Sullivan512-334-8973OpenCardiovascular18-09-01

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

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Mary Fraser512-421-3841OpenCardiovascular18-09-02

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 Stojanovic512-816-7399OpenOncology18-09-04W

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 Cardinal512-431-4868OpenCardiac Arrhythmia18-09-05W

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

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Mary Fraser512-421-3841OpenCardiovascular18-10-01

ANEURYSM RESEARCH REGISTRY PROTOCOL

Krishna Saini512-544-8070OpenAneurysm18-10-03

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

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Deb Cardinal512-431-4868OpenCardiac Arrhythmia18-10-05W

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, PhD512-651-8406OpenSurgery18-11-02

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

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Krishna Saini512-544-8070OpenOrthopedics18-11-03

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

Diantha Gonzales, PharmDOpenPharmacy18-11-05X

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

Aaron Bernstein512-750-6570OpenSurgery18-11-06

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

Bonnie Punske, PhD512-651-8406OpenCardiac Arrhythmia18-12-01

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 KlaasenOpenSurgery18-12-02

Pulmonary Hypertension Registry

Allison Brannen512-544-8174OpenNeonatal Medicine18-12-03

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

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Deb Cardinal512-431-4868OpenCardiac Arrhythmia18-12-04W

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, PhD512-651-8406OpenSurgery18-12-05W

Unpinning Termination Therapy for VT/VF

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Deb Cardinal512-431-4868OpenCardiac Arrhythmia18-12-06W

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

Neesha ThakkarOpenPharmacy18-12-08X

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

OpenPharmacy18-12-12X

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 Stojanovic512-816-7399OpenOncology19-01-01W

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

OpenNursing19-01-04X

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

Mary Fraser512-421-3841OpenCardiovascular19-01-05W

Cryo AF Global Registry

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Deb Cardinal512-431-4868OpenCardiac Arrhythmia19-02-01W

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

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Jeannine Schuman-McCoy512-901-1000OpenMaternal Fetal Medicine19-03-01

National Cardiogenic Shock Initiative

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Mary Fraser512-421-3841OpenCardiovascular19-03-02

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

Tonnyann Hurley512-544-0115OpenNursing19-03-03X

Comparing Fatigue in Medical Transport Teams

Timothy Farmer512-544-8190OpenNursing19-03-04X

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, RN903-566-7023OpenNursing19-03-06W

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

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Caroline Gleason512-493-6905OpenMaternal Fetal Medicine19-04-01

XIENCE 28 USA Study

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Mary Fraser512-421-3841OpenCardiovascular19-04-03

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

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Krishna Saini512-544-8070OpenNeurology19-04-05W

Improving Readmissions of Heart Failure Patients

Chrisettia Morgan682-352-2984OpenNursing19-04-10X

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

Lucy Koneri, RN, MSN915-238-3332OpenNursing19-04-12X

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 Stojanovic512-816-7399OpenOncology19-04-13W

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

Deb Cardinal512-431-4868OpenCardiac Arrhythmia19-05-01W

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

Mary Fraser512-421-3841OpenRadiology19-05-04W

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

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Deb Cardinal512-431-4868OpenCardiac Arrhythmia19-05-05W*

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

Lindsey Cossel615-974-9353OpenOncology19-06-02W

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 Gordon303-621-6197OpenOncology19-07-04W

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 Gordon303-621-6197OpenOncology19-08-02W

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

Deb Cardinal512-431-4868OpenCardiac Arrhythmia19-08-03

Activity in Women at Risk for Early Delivery (AWARE)

Caroline Gleason512-493-6905OpenMaternal Fetal Medicine19-08-05

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

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Caroline Gleason512-493-6905OpenMaternal Fetal Medicine19-09-02

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 Cardinal512-431-4868OpenCardiovascular19-09-03AW

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 Fraser512-421-3841OpenCardiovascular19-10-01

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, PhD512-651-8406OpenCardiovascular19-10-03

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

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Mary Fraser512-421-3841OpenCardiovascular19-10-04

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, PhD512-651-8406OpenCardiovascular19-10-05

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, MBBS512-544-8070OpenNeonatal Medicine19-10-06

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 Fraser512-421-3841OpenCardiovascular19-10-07

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

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Deb Cardinal512-431-4868OpenCardiovascular19-10-11W

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 Fraser512-421-3841OpenCardiovascular19-11-01

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

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Kari Wilhelmi952-955-8235OpenRegistry19-11-04W

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 Rodriguez512-451-0103OpenOphthalmology, Neonatal Medicine19-11-05

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

Open19-12-01A

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 Fraser512-421-3841OpenCardiovascular19-12-02

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

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Bonnie Punske, PhD512-651-8406OpenCardiovascular19-12-03

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 Rabin512-583-0217OpenOrthopedics19-12-04W

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

Krishna Saini512-5448070OpenOrthopedics19-12-05

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

Jake Rabin512-583-0217OpenOrthopedics19-12-06A

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 Fraser512-421-3841OpenCardiovascular20-01-01

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

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Mary Fraser512-421-3841OpenCardiovascular20-01-02

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 Saini512-544-8070OpenRespiratory Therapy20-01-03

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

OpenOncology20-01-05W

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 Stojanovic512-816-6423OpenOncology20-01-06W

(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 Stojanovic512-816-6423OpenOncology20-01-07W

(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 Stojanovic512-816-6423OpenOncology20-01-08W

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 Gordon512-816-7399OpenOncology20-01-09W

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 Gordon512-816-7399OpenOncology20-01-10W

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 Gordon512-816-7399OpenOncology20-01-11W

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

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Deb Cardinal512-431-4868OpenCardiovascular20-02-01

Maternal Infant Nutrition Study (MINT)

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Sara Dube512-471-0941OpenMaternal Fetal Medicine20-02-04W

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, PhD512-651-8406OpenCardiovascular20-03-02

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

Mary Fraser512-421-3841OpenCardiovascular20-03-03

(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 Stojanovic512-816-6423OpenOncology20-03-09W

The Cardiva VASCADE MVP VVCS Same Day Discharge Registry

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Deb Cardinal512-431-4868OpenCardiovascular20-04-10W

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, PhD512-651-8406OpenCardiovascular20-02-02

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 Cardinal512-458-9410OpenCardiac Arrhythmia04-05-03

Product Surveillance Registry

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Deb Cardinal512-458-9410OpenCardiovascular10-03-02

The Austin Brain Tumor Repository

Max Shpak512-544-8077OpenOncology10-05-03

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 Rabin512-583-0217OpenOrthopedics11-08-03

Arrhythmogenic Substrate Evaluation and Ablation in Brugada Syndrome

Deb Cardinal512-458-9410OpenCardiac Arrhythmia12-07-03

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 Rabin512-583-0217OpenOrthopedics12-09-03

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

Deb Cardinal512-458-9410OpenCardiovascular12-11-03

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 Fraser512-740-0631OpenCardiovascular12-12-05

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

Deb Cardinal512-458-9410OpenCardiovascular13-04-03

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 Cardinal512-458-9410OpenCardiovascular13-05-01

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 Fraser512-740-0631OpenCardiovascular13-06-02

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 Rabin512-583-0217OpenOrthopedics13-08-01

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

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Mary Fraser512-740-0631OpenCardiovascular13-10-02

Portico Re-Sheathable Transcatheter Aortic Valve System

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Mary Fraser512-740-0631OpenCardiovascular14-01-04

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

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Jake Rabin512-583-0217OpenOrthopedics14-01-05

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 Cardinal512-458-9410OpenCardiac Arrhythmia14-04-02

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 Fraser512-458-9410OpenCardiac Arrhythmia14-05-01

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

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Deb Cardinal512-458-9410OpenCardiac Arrhythmia14-06-04

AdaptResponse Study

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Deb Cardinal512-458-9410OpenCardiac Arrhythmia14-07-01

Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial (PERIGON)

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Bonnie Punske, PhD512-651-8406OpenCardiovascular14-12-02

Endurant Evo US Clinical Trial

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Bonnie Punske, PhD512-651-8406OpenCardiovascular15-04-03

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 Fraser512-740-0631OpenCardiovascular15-06-02

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 Fraser512-740-0631OpenCardiac Arrhythmia15-08-01

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

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Deb Cardinal512-458-9410OpenCardiac Arrhythmia15-08-04

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, PhD512-651-8406OpenCardiovascular15-09-01

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 Cardinal512-458-9410OpenCardiovascular15-12-02

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 Fraser512-740-0631OpenCardiovascular16-02-04

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, PhD512-651-8406OpenCardiovascular16-04-04

Genetics of Heritable Arrythmyia (Heritable Arrhythmia Genetics: HERITAGE)

Deb Cardinal512-458-9410OpenCardiac Arrhythmia17-02-01 (10-2017-02)

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

Krishna Saini512-544-8070OpenPharmacy17-03-02 (10-2017-07)

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

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Mary Fraser512-421-3841OpenCardiovascular17-03-04 (17-2017-05)

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

Caroline Gleason512-493-6905OpenMaternal Fetal Medicine17-03-06W (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, MDOpenOrthopedics17-05-01W

CarboClear Pedicle Screw System IDE Study

Carl Lauryssen, MDOpenSpine17-05-02W

TREAT: Treatment of ppROM with Erythromycin vs. Azithromycin Trial

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Caroline Gleason512-493-6905OpenMaternal Fetal Medicine17-06-01

Medtronic Attain Stability Quad Study

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Deb Cardinal512-458-9410OpenCardiac Arrhythmia17-06-02W

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

Andrea Torres512-439-1117OpenOrthopedics17-07-02

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, MDOpenNeurology17-07-04W

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

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Krishna Saini512-544-8070ClosedSpine17-08-02

Clinical Evaluation of the PartoSure™ Test

Richard Todd Hale, PhDo. 512-493-6927, c. 512-788-8980ClosedMaternal Fetal Medicine17-09-01

Phoenix Exoskeleton for SCI Users

Robert Rambusek512-544-8480ClosedRehabilitation17-12-02

TactiSense IDE SJM-CIP-10216

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Deb Cardinal512-431-4868ClosedCardiac Arrhythmia18-01-04W

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

Anthony Rudine, MDClosedNeonatal Medicine18-02-03

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 Fraser512-421-3841ClosedCardiovascular18-03-02

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 Gleason512-493-6905ClosedMaternal Fetal Medicine18-07-01

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

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Caroline Gleason512-439-6905ClosedMaternal Fetal Medicine18-11-04W

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 Arnett512-544-8163ClosedBariatrics19-03-05

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

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Krishna Saini512-544-8070ClosedSpine19-07-01

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

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Deb Cardinal512-458-9410ClosedCardiac Arrhythmia08-11-09

QuickFlex 1258T – Left Heart Pacing Lead Post Approval Study

Deb Cardinal512-458-9410ClosedCardiac Arrhythmia10-11-04

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

Deb Cardinal512-458-9410ClosedCardiac Arrhythmia10-12-01

Ranolazine ICD Trial (RAID)

Deb Cardinal512-458-9410ClosedCardiac Arrhythmia11-04-01

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

Deb Cardinal512-458-9410ClosedCardiac Arrhythmia11-05-01

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 Fraser512-740-0631ClosedCardiac Arrhythmia11-06-01

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 Fraser512 740 0631ClosedCardiovascular11-09-03

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 Cardinal512-458-9410ClosedCardiac Arrhythmia11-11-04

Renal Denervation in Patients with Uncontrolled Hypertension SYMPLICITY HTN-3

Mary Fraser512-740-0631ClosedCardiovascular11-11-05

Accent MRI Pacemaker and Tendril MRI Lead IDE Study

Mary Fraser512-740-0631ClosedCardiac Arrhythmia12-05-01

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 Fraser512-740-0631ClosedCardiovascular12-08-02

Continued Access to PREVAIL (CAP2)

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Deb Cardinal512-458-9410ClosedCardiovascular12-09-05

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

Deb Cardinal512-458-9410ClosedCardiac Arrhythmia12-10-01

INGEVITY Active Fixation and Passive Fixation Pace/Sense Lead Study

Mary Fraser512-740-0631ClosedCardiac Arrhythmia12-12-01

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 Rabin512-583-0217ClosedOrthopedics13-02-01

ImageReady MR Conditional Pacing System SAMURAI Clinical Study

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Deb Cardinal512-458-9410ClosedCardiovascular13-03-01

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 Fraser512-740-0631ClosedCardiovascular13-12-02

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 Cardinal512-458-9410ClosedCardiac Arrhythmia14-07-02

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

Deb Cardinal512-458-9410ClosedCardiac Arrhythmia14-09-01

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

Jake Rabin512-583-0217ClosedOrthopedics14-10-01

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

Krishna Saini512-544-8070ClosedRehabilitation14-11-01

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

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Deb Cardinal512-458-9410ClosedCardiac Arrhythmia14-11-02

CardioMEMS HF System Post Approval Study

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Mary Fraser512-740-0631ClosedCardiovascular14-11-05

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, PhD512-651-8406ClosedCardiovascular15-01-01

SNP-based microdeletion and aneuploidy registry (SMART)

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Caroline Gleason512-493-6905; c- 210-683-9335ClosedMaternal Fetal Medicine15-04-01

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, PhD512-651-8406ClosedNephrology15-07-02

Anthropometric Data Collection of the Bariatric Population Hill-Rom

John Archibeque, MSNClosedBariatrics15-07-03

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

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Deb Cardinal512-458-9410ClosedCardiac Arrhythmia15-08-03

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

Mary Fraser512-740-0631ClosedCardiovascular15-08-06

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 Fraser512-740-0631ClosedCardiovascular15-10-01

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

Bonnie Punske, PhD512-651-8406ClosedCardiovascular15-10-02

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

Krishna Saini512-544-8070ClosedNeurology15-10-03

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 Fraser512-740-0631ClosedCardiovascular15-12-03

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

Deb Cardinal512-458-9410ClosedCardiac Arrhythmia16-02-01

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 Fraser512-740-0631ClosedCardiovascular16-02-02

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 Rodriguez512-451-0103ClosedNeonatal Medicine16-04-01

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

Andrea Torres972-849-1198ClosedOrthopedics16-04-02

Early Results of 900 Consecutive, Anterior Approach Total Hip Arthroplasties

Andrea Torres972-849-1198ClosedOrthopedics16-04-03

MULTIPOINT PACING POST MARKET STUDY (MPP PMS)

Mary Fraser512-740-0631ClosedCardiac Arrhythmia16-08-01

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 Fraser512-421-3841ClosedCardiovascular17-02-02 (17-2017-01)

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

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Deb Cardinal512-458-9410ClosedCardiac Arrhythmia17-03-01 (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 Fraser512-421-3841ClosedCardiovascular17-03-03 (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 Cardinal512-458-9410ClosedCardiac Arrhythmia17-04-01

Treatment for ppROM with Erythromycin vs. Azithromycin Trial

Caroline Gleason512-493-6905ClosedMaternal Fetal Medicine17-04-03W *

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 White615-524-4149ClosedOncology17-07-03W

Long Term Follow-Up Study of ROADSTER 2 Patients

Bonnie Punske, PhD512-651-8406ClosedCardiovascular17-08-01