Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
This study enrolls people who have mitral regurgitation (MR). Mitral regurgitation happens when the heart’s mitral valve does not close tightly. The purpose of this trial is to evaluate a new investigational device called the Tendyne™ Mitral Valve System. The Tendyne Mitral Valve System is designed for the treatment of a diseased, damaged or malfunctioning mitral valve. This trial will collect information on how safe and effective this device is to treat a leaking mitral valve compared to the commercially available MitraClip® System.
You will be randomly picked, like the flip of a coin, to have either the endyne™ Mitral Valve System or the MitraClip® System used during your procedure. You will need to return for follow up appointments at one-month, six-months, one year, and annually for 5 years after your initial procedure. The study team will also call you from time to time to learn how you have been doing. Study takes place at Gates Vascular Institute.
This trial is a prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, moderate-to-severe or severe mitral regurgitation or severe MAC.
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
-Adults ages 18+.
-Have symptomatic, moderate-to-severe/severe mitral regurgitation (MR) or severe mitral annular calcification (MAC)
-Your medical providers have decided a transcatheter therapy is more appropriate than open surgery.
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