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​​For information on a research trial, contact the Research Office at 469.814.4720 or ResearchTHHBP@bswhealth.org.​


Congestive Heart Disease

​Heartmate III™

Principal Investigator: Brian Lima, MD

Evaluate the safety and efficacy of injecting MPCs (150 million dose) into the native myocardium of LVAD patients.


​Coronary Artery Disease

Affects

Principal Investigator: ​David L. Brown, MD

To correlate the Heartflow technology to gold standard of cardiac catheterization with FFR after a positive SPECT scan.

​Chronic Total Occlusion

Principal Investigator: Srini P. Potluri, MD

This is a prospective registry of all patients at The Heart Hospital Baylor who undergo attempt at coronary CTO intervention.

EVOLVE

Principal Investigator: Molly Szerlip, MD

Assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with the SYNERGY™​ Stent System.


Electrophysiology

ADAPT

Principal Investigator: Hafiza H. Khan, MD

Adapt Response Clinical Trial - Test the hypothesis that market-released CRT devices which contain the ADAPTIVE CRT algorithm have a superior outcome compared to standard CRT devices and CRT indicated patients with normal AV conduction in left bundle branch block.

CLE Research

Principal Investigator: Brian DeVille, MD

To determine if evaluating CIEDs using CareLink Express® can lead to shorter time to interrogation in the Emergency Department compared to evaluation of devices using traditional evaluation procedures.

​​Enhance

Principal Investigator: Tran Ho, MD

To analyze the effect of the left ventricular lead pacing location and the non-left bundle branch block heart failure patient population. The LV lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay or the physician standard of care implant approach.

Lariat®

Principal Investigator: Brian DeVille, MD

To assess the outcome of patients undergoing left atrial appendage ligation or closure with the Sentre Heart Lariat®​ device as a stand-alone procedure at the participating centers.

Medtronic EGD

Principal Investigator: Brian DeVille, MD

Determine the correlation between the rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation.

PAN

Principal Investigator: Brian DeVille, MD

A registry to better understand the safety of Medtronic's market-released products.

Precept

Principal Investigator: Brian DeVille, MD

Demonstrate the safety and effectiveness of the THERMOCOOL SMARTTOUCH® sf catheter in the treatment of drug refractory symptomatic persistent with atrial fibrillation following standard electrophysiology mapping and rf ablation procedures.

PPM in TAVR

Principal Investigator: Brian DeVille, MD

Assess the incidence at 90 days of ventricular pacing in patients undergoing permanent pacemaker placement after TAVR.

Quartet™ 1457Q

Principal Investigator: Adam Shapira, MD

To assess the safety of the model 1457Q Quartet­™ LV lead at three months in a patient population indicated for cardiac resynchronization therapy.


Heart Valve

4D CT TAVR

Principal Investigator: Deepika​ Gopal, MD

4D CT to Evaluate Valve Thrombosis after Transcatheter Aortic Valve Replacement - Identify the incidence of valve thrombosis in patients referred for 4D CT evaluation due to clinical and/or echocardiographic criteria.

CardiAQ™ - Fortis

Principal Investigators: Michael Mack, MD​

Early feasibility study of CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems) for the treatment of moderate to severe mitral regurgitation.

COAPT

Principal Investigator: Paul Grayburn, MD

Cardiovascular Outcomes Assessment of the MitraClip® Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation - Compare the performance of the investigational MitraClip® system plus optimal drug therapy with optimal drug therapy alone.

CT Pain

Principal Investigator: Robert Hebeler, Jr., MD

Evaluation of a new method of reducing pain associated with interpleural tubes following thoracic surgery.

CTSN - Tricuspid

Principal Investigator: Robert L. Smith, II, MD

Evaluate the efficacy and safety of performing tricuspid valve (TV) repair in patients undergoing mitral valve surgery with either moderate tricuspid regurgitation (TR) or less than moderate TR with tricuspid annular dilation.

Direct Flow

Principal Investigators: David L. Brown, MD / Michael Mack, MD

To demonstrate the safety and effectiveness of the Direct Flow Medical Transcatheter Aortic Valve System in Subjects with severe aortic stenosis who are considered extreme or high risk for surgical valve replacement.

Galileo

Principal Investigator: Molly Szerlip, MD

Global study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement (TAVR) to optimize clinical outcomes.

​Partner III

Principal Investigators: David L. Brown, MD / Michael Mack, MD

Establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in low-risk patients requiring aortic valve replacement who have severe, calcific, symptomatic aortic stenosis.

Portico™

Principal Investigators: David L. Brown, MD / Michael Mack, MD

To evaluate the safety and effectiveness of the SJM Portico™ Transcatheter Heart Valve and Delivery Systems (Portico) via transfermoral and alternative delivery methods in high risk patients.

Post MRV Afib

Principal Investigator: James Edgerton, MD

Assess the incidence of atrial fibrillation (Afib) events after discharge in patients with isolated post-mitral valve/replacement or post-mitral valve repair/replacement with tricuspid valve repair/replacement.

PVL in TAVR

Principal Investigator: Deepika Gopal, MD

To assess the agreement between the correlations between two testing methods, the MRI and TTE, for PVL grading.

Reflect I (Embolic Protection)

Principal Investigator: David L. Brown, MD

Evaluate the safety and efficacy of the TriGuard™ HDH embolic deflection device in patients undergoing TAVI, in comparison with an active control group of patients undergoing unprotected TAVI.​

SITRAL

Principal Investigator: Robert L. Smith, II, MD

The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at high risk for mitral valve surgery due to the extent of calcification. 

SURTAVI

Principal Investigator: David L. Brown, MD

Evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI.


Hypertension

Radiance

Principal Investigator: Srini P. Potluri, MD

The "Radiance-HTN" Study - A Study of the ReCor Medical Paradise System in Clinical Hypertension - Demonstrate the ability of the Paradise® System to effectively reduce systolic daytime ambulatory BP (ABP) in hypertensive subjects.


Interventional Cardiology

Resolute Integrity™

Principal Investigator: Srini P. Potluri, MD

​A post-approval study to conduct a prospective, multi-center evaluation of the procedural and clinical​ outcomes of subjects that are treated with the commercially available 34 MM and 38 MM Medtronic Resolute Integrity­™ ZOTAROLIMUS-ELUTING coronary stem system.


Pulmonary Hypertension

Opus

Principal Investigator: Sahil Bakshi, DO

OPsumit USers Registry - Registry developed to characterize the safety profile (including primarily potential serious hepatic risk) and to describe clinical characteristics and outcomes of patients with pulmonary hypertension who are newly treated with Opsumit® in the post-market setting.

PAH Biobank

Principal Investigator: Sahil Bakshi, DO

National Biological Sample and Data Repository for Pulmonary Arterial Hypertension - Establish a national biorepository of biological samples and genetic data of patients with WHO Group 1 PAH.


Vascular Disease

​​IVUS

Principal Investigator: William P. Shutze, III, MD

A Prospective Randomized Feasibility Trial Comparing Angiography and Angiography with IVUS for treatment of hemodialysis access failures - Determine if the data IVUS provides is able to recognize lesions that would have gone untreated and to determine whether or not this impacts outcomes.

Pivotal

​Principal Investigator: William T. Brinkman, MD

​Determine whether the GORE® TAG® Thoracic Branch endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

Valiant™ Evo

Principal Investigator: William T. Brinkman, MD

Valiant Evo Thoracic Stent Graft System - Demonstrate the safety and effectiveness of the Valiant™ Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.

Vascular Post Market Review

Principal Investigator: Dennis R. Gable, MD

Vascular Post Market Review - CardioCel® CEA - Confirm that properties of CardioCel® provide operative benefit to surgeons when compared to Dacron, CorMatrix, and all other bovine pericardium not treated with proprietary ADAPT engineering.

WISCR

Principal Investigator: Dennis R. Gable, MD

Designed to collect clinical reference images using the study device (Spectral MD DeepView Wound Imaging System 2.0) in subjects with a variety of acute and chronic wounds.

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Disclosure Statement

CLINICAL RESEARCH