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

Testing SAPIEN X4 valve for worn-out aortic bioprosthetic valves.

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Study Purpose: This research aims to test the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) for people with a failing aortic bioprosthetic valve. A bioprosthetic valve is a type of valve made from animal tissues used to replace a diseased heart valve. Aortic refers to the main artery in the body. This study is for individuals who are at high or greater risk during surgery.

Study Type: This is a prospective, single-arm, multicenter study. This means that the study looks forward in time, involves one group of participants, and is conducted at multiple locations.

  • Participation involves a medical procedure to replace the failing valve with the SAPIEN X4 THV.
  • Participants will be monitored for safety and how well the new valve works.
  • Risks include possible complications during or after the procedure.

Eligibility: To join, you must have a failing aortic bioprosthetic valve, be at high or greater surgical risk, and meet other specific criteria. There are also several conditions that would make you ineligible for this study, such as recent heart attack or severe kidney problems.

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Study details
    Aortic Valve Insufficiency
    Aortic Valve Stenosis

NCT05172973

Edwards Lifesciences

13 December 2024

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