Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation .
This study is for people undergoing surgery for mitral regurgitation (MR). Mitral regurgitation is a condition when your heart’s mitral valve does not close tightly which causes blood to flow backwards in your heart. The purpose of this study is to learn how safe and effective one value repair system is (the PASCAL System, an investigational device) compared to another one (the MitraClip System).
You will be asked to be a part of this study by your doctor. The study is for people who, despite medical therapy for their MR, have been determined to have symptoms due to heart failure. For this your doctor may have suggested transcatheter mitral valve treatment. Once implanted, the device is designed to reduce the amount of leakage across your heart valve. Patients enrolled in this study will be randomly selected (like the flip of a coin) into one of two groups. Each group will have a different valve device used in their surgery. You will be asked to return for a study visit at 1 month, 6 months, and annually until 5 years after your procedure.
Study takes place at Buffalo General Medical Center and Gates Vascular Institute, 875 Ellicott St, Buffalo, NY 14203.
CLASP IID Cohort: The objective of this pivotal clinical trial is to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip System in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.
CLASP IIF Cohort: The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System and GDMT compared to the MitraClip System and GDMT for the treatment of moderate-to-severe (3+) or severe (4+) FMR in symptomatic heart failure patients who have been determined by the site???s local multidisciplinary heart team to be eligible for transcatheter mitral valve repair.
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Adults ages 18+.
Have severe degenerative mitral regurgitation, and are considered prohibitive risk for mitral valve surgery by your heart team.
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