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Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Join our clinical trial for the Edwards PASCAL heart valve repair system.

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

This study is testing the **Edwards PASCAL Transcatheter Valve Repair System**, which is a new way to fix a heart problem called **tricuspid regurgitation (TR)**. TR happens when the heart's tricuspid valve doesn't close right, causing blood to leak backward. The goal is to see if this new method is safe and works well for people who can't have surgery because it's too risky.

Participants in this study will be cared for with the new device and regular medicine, or just with regular medicine. They will have follow-up visits after going home, at 30 days, 3 months, 6 months, and yearly for 5 years.

  • This study lasts up to 5 years with regular check-ups.
  • Participants must be at least 18 years old and have severe TR.
  • Exclusion includes recent heart surgeries or certain heart conditions.

People who join will need to agree to the study rules and be able to attend all visits. It is important to talk with your doctor to understand if this study is a good fit for you and the risks involved.

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Study details
    Tricuspid Regurgitation
    Tricuspid Valve Insufficiency
    Tricuspid Valve Disease

NCT04097145

Edwards Lifesciences

26 January 2025

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  • You can expect the study team to contact you via email or phone in the next few days.
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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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