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Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Join our study on the PASCAL heart valve repair system!

Recruiting
18 years and older
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

The study is testing a new way to fix a heart problem called tricuspid regurgitation (TR), where the heart valve doesn't close properly. The Edwards PASCAL Transcatheter Valve Repair System is being studied to see if it is safe and works well for people who have severe TR and are at moderate to high risk of dying from valve surgery. This trial will compare the new device plus regular medicine to just regular medicine alone. Patients will have follow-up visits right after leaving the hospital, then at 30 days, 3 months, 6 months, and every year for up to 5 years.

  • Study Duration: Follow-up visits for up to 5 years.
  • Eligibility: Must be 18 or older with severe TR and high surgical risk.
  • Risks: Includes potential complications from the device and procedure.
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Study details
    Tricuspid Regurgitation
    Tricuspid Valve Insufficiency
    Tricuspid Valve Disease

NCT04097145

Edwards Lifesciences

18 May 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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