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J-Valve Transfemoral Pivotal Study

Join our study on a new heart valve treatment option!

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

This study is testing a new heart valve, the **J-Valve Transfemoral System**, for people with a severe heart valve problem called "aortic valve regurgitation (AR)". AR is when the heart's aortic valve doesn't close tightly, causing blood to flow backward. This study focuses on patients who are too risky for typical heart surgery.

Participants will be observed up to 5 years after getting the J-Valve. The study will also use a special heart scan called **Cardiac Magnetic Resonance (CMR)** to see how well the heart improves after treatment. It will check heart shape changes and differences between men and women.

  • **Participation**: Up to 194 people in the U.S., Canada, Europe, and Japan.
  • **Time Commitment**: Follow-up lasts 5 years after the procedure.
  • **Requirements**: Must have severe AR and be at high risk for surgery.

Participants should not have any previous heart valve implants or severe other heart valve diseases. If interested, you’ll need to agree to all check-ups after the procedure.

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Study details
    Aortic Valve Regurgitation
    Aortic Valve Disease Mixed

NCT06455787

JC Medical, Inc., an affiliate of Edwards Lifesciences LLC

17 October 2026

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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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