Study of Edwards SAPIEN 3SAPIEN 3 Ultra Transcatheter Heart Valve for Treating Failing Aortic Bioprosthetic Valves

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves in patients who have a failing aortic bioprosthetic valve. This prospective, single-arm, multicenter study focuses on patients with severe aortic stenosis or a failing surgical or transcatheter bioprosthetic valve. The study aims to assess important outcomes such as mortality and stroke within one year after valve implantation. Participants will undergo transcatheter aortic valve replacement TAVR using the Edwards SAPIEN 3 or SAPIEN 3 Ultra heart valve systems with their delivery devices. The study includes only one treatment group where patients receive this device to replace their failing valve. This procedure is performed through various access routes depending on individual anatomy and clinical assessment. During the study, participants will have assessments including heart function evaluations, symptom questionnaires like the Kansas City Cardiomyopathy Questionnaire, exercise capacity tests such as the six-minute walk test, and measurements of valve gradients at 30 days. Researchers will monitor safety and effectiveness outcomes including all-cause mortality and stroke for one year. The total duration of involvement varies but includes regular follow-up visits to assess heart performance and patient wellbeing after the procedure.

PARTNER 3 Trial - Aortic Valve-in-Valve