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


​Cardiology

AFFECTS

Principal Investigator: ​David L. Brown, MD

Assessment of Fractional Flow Reserve Computed tomography versus Single Photo Emission Computed tomography in the diagnosis of hemodynamically significant coronary artery disease.

EVOLVE

Principal Investigator: Molly Szerlip, MD

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

OPUS

Principal Investigator: Sahil Bakshi, DO

Prospective observational drug 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.

Pioneer HF

Principal Investigator: Steven Kindsvater, MD

The primary objective of this study is to assess the effect of in-hospital initiation of sacubitril/valsartan tablets vs enalapril on the time-averaged proportional change of NT-proBNP from baseline in patients who have been stabilized following hospitalization for acute decompensated heart failure and reduced ejection fraction.

​​​Quartet™ 1457Q

Principal Investigator: Adam Shapira, MD

Assess the safety of the 1457Q Quartet™ Quadripolar LV lead at three months in a patient population indicated for cardiac resynchronization.

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® Renal Denervation System to effectively reduce systolic daytime ambulatory BP (ABP) in hypertensive subjects.

Ranger™

Principal Investigator: Srini P. Potluri, MD

To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries.

RenalGuard®

Principal Investigator: Elizabeth Holper, MD

The  primary objective of this clinical trial is to evaluate whether the RenalGuard® Therapy is superior to a well-studies standard hydration protocol for preventing the incidence of contrast induce nephropathy after a catheterization procedure which uses iodinated contrast media.


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.​

Amaze

Principal Investigator: J. Brian DeVille, MD

Left Atrial Appendage Ligation with the Lariat® Suture Delivery System as adjunctive therapy to pulmonary vein isolation for persistent or longstanding persistent atrial fibrillation.​

CareLink Express®

Principal Investigator: J. Brian DeVille, MD

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. The goal of the research is to determine if patients evaluated by CareLink Express® have a reduction of "time to interrogation" compared to the traditional patient cohort.

​​Enhance

Principal Investigator: Trieu Q. Ho, MD

CRT Implant Strategy Using the Longest Electrical Delay for Non-LBBB Patients - Purpose is 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: J. Brian DeVille, MD

To assess the utility of left atrial appendage ligation with the SentreHEART Lariat®​ device in improving the success of ablation in participants with persistent atrial fibrillation.

Medtronic EGD

Principal Investigator: J. 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: J. Brian DeVille, MD

Medtronic Product Surveillance Registry (Cardiac Rhythm) - Purpose of this registry is to better understand the safety and effectiveness of Medtronic market-released products.

PPM in TAVR

Principal Investigator: J. Brian DeVille, MD

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

PRECEPT

Principal Investigator: J. Brian DeVille, MD

Demonstrate the safety and effectiveness of the THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug refractory in symptomatic, persistent atrial fibrillation following standard electrophysiology mapping and RF​ ablation procedures.


Interventional

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.

Resolute Integrity™

Principal Investigator: Srini P. Potluri, MD

Resolute Integrity™ US Extended Length Sub-Study (RI-US XL) - 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.


Mitral

SITRAL

Principal Investigator: Robert L. Smith, II, MD

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 or deemed inoperable due to the extent of calcification. 


Pulmonary Hypertension

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.


Surgery

CT Pain

Principal Investigator: Robert F. Hebeler, Jr., MD

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

CTSN MMR SMR 5Y

Principal Investigator: Michael Mack, MD

This is a continuation of two CTSN randomized trials, the SMR and MMR trials, for the purpose of assessing the long-term outcomes of the index cardiac surgical therapy in patients with ischemic MR.

HeartMate III™

Principal Investigators: Shelley Hall​, MD

Evaluate the safety and efficacy of injecting MPCs (150 million dose) into the native myocardium of LVAD recipients. The secondary objectives are to explore the functional and psychological effects of injecting MPCs (150 million dose) into the native myocardium of LVAD recipients.

Post MRV Afib

Principal Investigator: James R. Edgerton, MD

Assessment of 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.​


Transcatheter Aortic Valve Replacement

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 at The Heart Hospital Baylor Plano.

Early TAVR

Principal Investigator: Elizabeth Holper, MD

Establish the safety and effectiveness of the Edwards SAPIEN 3™ (Edwards Lifesciences™, Irvine, California) Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.

Galileo

Principal Investigator: Molly Szerlip, MD

Assess whether a rivaroxaban-based antithrombotic strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).

MANTA Study

Principal Investigator: David L. Brown, MD

Demonstrate the safety and effectiveness of MANTA in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath for purposes of obtaining a PMA approval in the U.S.

​Partner 3

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

Establish the safety and effectiveness of the Edwards SAPIEN 3™ (Edwards Lifesciences™, Irvine, California) Transcatheter Heart Valve (THV) in patients with severe, calcific, symptomatic aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

Portico™

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

Portico™ Re-Sheathable Transcatheter Aortic Valve System US IDE Trial -  The Portico™ clinical study is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico™ Transcatheter Heart Valve and Delivery Systems (Portico) via transfermoral and alternative delivery methods.

PVL in TAVR

Principal Investigator: Deepika Gopal, MD

A Novel Imaging Approach to Assess Paravalvular Leak for Transcatheter Valve Replacement - Assess the agreement between cMRI PVL grading (based on regurgitant fraction) and TTE PVL grading (based on pressure, half-time, and the ratio of the jet arch to the circumference of the annulus).

Reflect I​

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.​

​SURTAVI CONTINUED ACCESS

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.


Transcatheter Mitral Valve Replacement

CardiAQ-Fortis

Principal Investigator: Michael Mack, MD

Evaluate the safety and function of the CardiAQ Transcatheter Mitral Valve Implant System with the Transseptal and Transapical Delivery Systems.


Vascular

​​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.


Vascular Surgery

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.

​WISCR

Principal Investigator: Dennis R. Gable, MD

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 (including but not limited to: burns, diabetic foot ulcers, venous stasis ulcers and others).​​

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Disclosure Statement

CLINICAL RESEARCH