Safety and Effectiveness of the Edwards SAPIEN X4 Balloon-Expandable Transcatheter Heart Valve in Patients With Failing Aortic Bioprosthetic Valves

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Edwards SAPIEN X4X4S Transcatheter Heart Valve THV in people with failing aortic bioprosthetic valves who are at high or greater surgical risk. This prospective, single-arm, multicenter study focuses on treating aortic valve insufficiency and stenosis using a balloon-expandable valve system designed for patients needing valve replacement. Participants receive a transcatheter aortic valve replacement TAVR using the SAPIEN X4 or X4S valve. The study includes two groups those with failing aortic surgical valves and those with failing aortic transcatheter heart valves. The valve implantation is done as a device procedure during the treatment phase. During the study, participants are monitored for one year to assess outcomes including death and stroke. Other evaluations include heart function assessed by the Kansas City Cardiomyopathy Questionnaire and New York Heart Association functional class at 30 days and one year after the procedure. The study involves follow-up visits to monitor safety and effectiveness over this period.

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves