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


​Cardiology & Pulmonary Hypertension

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.

PRECISION GRX

Principal Investigator: Srini P. Potluri, MD

A post-market registry to continue market surveillance of the second generation CorPath® GRX System by Corindus Vascular Robotics. The CorPath GRX System offers improvements in procedural control, enhanced workflow and radiation protection for physicians, patients and staff.

​​​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.

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.

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.


​Electrophysiology & LAA

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.​

Amulet

Principal Investigator: Srini P. Potluri, MD

A study to assess the safety and efficacy of a new device, the Amulet (Abbott, Inc.) intended to reduce the risk of stroke and hemmorrhagic events in patients who have 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.

​​​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.


​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.

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.

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.​


VALVE

4D CT TAVR

Principal Investigator: Ambarish 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.

CardiAQ-Fortis

Principal Investigator: Robert L. Smith, II, MD / Molly Szerlip, MD

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

CardioBand

Principal Investigator: Robert L. Smith, II, MD

A randomized, control trial of CardioBand to optimized medical management for treatment of functional mitral regurgitation in patients who are poor surgical candidates.

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.

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.

​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).

PASCAL

Principal Investigator: Robert L. Smith, II, MD

A nonrandomized safety and efficacy study for patients with severe mitral valve regurgitation, which hopes to offer this unique PASCAL edge-to-edge repair to a much wider range of mitral regurgitation patients.

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).

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.


​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.

​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.

PSIDE

Principal Investigator: William T. Brinkman, MD

A physician supported/initiated study, in which patients with Type A dissections who are deemed at high risk for surgery will be considered for enrollment. Stents specifically designed for use in the ascending aorta will facilitate treatment.

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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​​​​​​​​​BAYLOR SCOTT & WHITE RESEARCH ​INSTITUTE​