Evaluating the Safety and Effectiveness of Balloon-Expandable SAPIEN X4 and X4S Heart Valves in Severe Calcific Aortic Stenosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Edwards SAPIEN X4 and X4S Transcatheter Heart Valves THV in people with symptomatic, severe, calcific aortic stenosis. This is a prospective, single group, multicenter study that also includes a separate registry for participants with bicuspid aortic valve morphology. Participants will undergo transcatheter aortic valve replacement TAVR using the SAPIEN X4 or X4S valves. Those with bicuspid aortic valves will be enrolled in a distinct registry but will also undergo TAVR. The study focuses on implantation of these balloon-expandable heart valves as the main intervention. During the study, participants will be monitored for safety and outcomes like death and stroke over one year. Researchers will assess heart function through the Kansas City Cardiomyopathy Questionnaire and check for complications such as paravalvular leak and the need for a permanent pacemaker within 30 days. The total participation time includes follow-up assessments up to one year after valve implantation.

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve