Heart Valve Replacement for People with Tricuspid Regurgitation/Insufficiency Heart Murmur
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
This study enrolls people who have been diagnosed with Tricuspid Regurgitation (TR). The purpose of this study is to look at the safety and effectiveness of this new investigational device compared to the standard medical treatment.
This study will last for approximately 5 years. There will be follow ups at 1, 3, 6, 12 months, then once a year. The first visit will consist of a questionnaire, physical exam, echocardiogram (imaging of the heart), and bloodwork collection. After speaking with you and looking at the labwork, if your cardiologist still thinks this may be of benefit to you, you may move forward to the procedure. This procedure involves a small device being implanted into your heart. A small cut is made in your groin where your doctor can access the large vein in your leg (femoral vein). The device can enter this vein on a wire, which can then be guided up to your heart where it will be placed . This is the least invasive way of getting into the heart and is called a transcatheter valve repair. This study takes place at Buffalo General Medical Center, Gates Vascular Institute, and UBMD Outpatient Clinics in Buffalo NY.
The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter tricuspid valve repair with OMT compared to OMT alone in the treatment of patients with symptomatic severe tricuspid regurgitation.
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Adults ages 18+
Diagnosed with Tricuspid Regurgitation/Insufficiency
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