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

Study on SAPIEN X4 valve for aortic bioprosthetic valve issues.

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Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is testing a heart valve called SAPIEN X4 to see if it works safely for people with a failing aortic bioprosthetic valve (a worn-out artificial valve in the heart). The study will be done in many places and only has one group of participants. To be part of this study, you must have a failing valve, be at high risk for surgery, and agree to the study rules.

However, you cannot join if you have certain heart conditions, recent heart problems, or if your health makes it unsafe. The study will check if the SAPIEN X4 valve is good for people who can't have regular heart surgery. This study requires you to visit multiple centers, and you will be closely monitored throughout.

  • Length of Study: Several months, with multiple visits.
  • Risks: Potential complications from the procedure or device.
  • Compensation: Not mentioned, but discuss with the study team.

If you think you qualify, talk to your doctor to learn more about joining and how it might help you.

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Study details
    Aortic Valve Insufficiency
    Aortic Valve Stenosis

NCT05172973

Edwards Lifesciences

13 December 2024

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