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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

LEVO-CTS

Principal Investigator: Randy Marcel, MD

Evaluate if an investigational medicine, called LEVOSIMENDAN, is safe and effective in patients with left ventricular systolic dysfunction who are undergoing cardiac surgery on cardiopulmonary bypass.

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.

Artemis

Principal Investigator: David L. Brown, MD

Affordability and Real-World Antiplatelet Treatment Effectiveness - Assess the impact of copayment reduction by equalizing the copayment of clopidogrel and ticagrelor. Will assess prescribing patterns, patient medication adherence, and clinical outcomes up to one year.

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.

Cryoballoon

Principal Investigator: Brian Deville, MD

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

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.

PAN

Principal Investigator: Brian DeVille, MD

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

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: 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.

CardiAQ™ - Fortis

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

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.

MVR Post-OP AFIB

Principal Investigator: James Edgerton, MD

Assessing the incidence of AFIB after surgical MVR placement out to one year.

Partner III

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

Establish the safety and effectiveness of the 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.

PVL in TAVR

Principal Investigator: Ambrish 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

This study is a prospective, single-blind, randomized trial in the United States, Europe, and Israel. Subjects with indications for TAVR will be randomized 2:1 to one of two treatment arms:

  • Intervention: TAVR with the TriGuard HDH embolic deflection device
  • Control: standard unprotected TAVR

All subjects will be followed in-hospital and at 30 and 90 days with MRI and neuropsychological testing.

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. The study will include subjects undergoing mitral valve replacement with the Edwards SAPIEN 3 heart valve by a surgical approach. Subjects will undergo follow-up visits at 30 days, six months, and 12 months post-procedure.


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.


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

EVAS I (Nellix®)​

Principal Investigator: Jay Vasquez, Jr., MD

A prospective, multicenter, single-arm safety and effectiveness study of endovascular abdominal aortic aneurysm repair using the Nellix® system: pivotal and continued access study.

Excluder

Principal Investigator: William P. Shutze, III, MD

Evaluation of the GORE Excluder Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-Iliac Aneurysms - Designed to assess the safety and efficacy of the IBE device in subjects with common iliac artery aneurysms or aorto-iliac aneurysms.

GREAT

Principal Investigator: Dennis R. Gable, MD

GREAT Outcomes Evaluation is a prospective observational cohort registry designed to obtain data on device performance and clinical outcomes of patients treated with GORE endovascular aortic products.

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.

Thoraflex™ Hybrid

Principal Investigator: William T. Brinkman, MD

Evaluation of the Thoraflex™ Hybrid Device - Assess the effectiveness and safety of the Thoraflex™ Hybrid device in the treatment of aortic disease affecting the aortic arch and the descending aorta, with, or without, involvement of the ascending 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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CLINICAL RESEARCH