Edwards Lifesciences
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team
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. Patients will be seen for follow-up visits at discharge, 30 days, 3 months, 6 months, and annually through 5 years.
Inclusion Criteria: * Eighteen (18) years of age or older * Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. * Severe or greater tricuspid regurgitation * New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months * Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team * Patient is able and willing to give informed consent, follow protoco…
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Optimal Medical Therapy alone in patients with tricuspid regurgitation
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation