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


Valve

Early TAVR (Aortic)

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.

CardioBand (Mitral)

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.

PASCAL (Mitral)

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.​


Cardiology​

Pioneer HF

Principal Investigator: Steven Kindsvater, MD

A study 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.


Electrophysiology

Amulet (LAA)

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 hemorrhagic​ events in patients who have atrial fibrillation.

PRECEPT (AF)

Principal Investigator: J. Brian DeVille, MD

A multicenter, international study to 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.​​


​Vascular

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).

Pivotal

Principal Investigator: William T. Brinkman, MD

A study to 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.​

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