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CLASP II Trial for Adults with Tricuspid Regurgitation (TR)
Protocol: SITE00000134
Full Title
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation
Description
Tricuspid regurgitation (TR) is a condition where the tricuspid valve in the heart does not close all the way. This causes blood to leak backwards which causes the heart to work harder than a healthy heart. It can lead to symptoms such as shortness of breath and tiredness. Severe untreated cases of TR can lead to heart failure.

The University at Buffalo (UB) is looking for adults with TR for a clinical trial that is testing the impact of the PASCAL repair system. The small PASCAL device is implanted into the heart via a small cut in their leg to repair the tricuspid valve.

Following the procedure, participants will complete follow-up visits at 30 days, 6 months, 1 year and 2 years. They will complete medical exams, blood work, have ankle measurements, walking tests, and other surveys.

Participants will receive up to $350 for completing all study visits.
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
Adults ages 18+
Diagnosed with Tricuspid Regurgitation/Insufficiency
Age Group: Adults
Principal Investigator: VIJAY IYER
ClinicalTrials.gov: Open Study
Contact(s)
COURTNEY BISHOP
cabishop@buffalo.edu
+1 716-888-4859

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