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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Join our study to test a heart valve treatment option.

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

The Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial tests a new way to fix a leaky heart valve without surgery. This problem, called mitral regurgitation (MR), happens when the heart valve doesn’t close properly, causing blood to flow backward. The study compares two treatments: the Edwards PASCAL system and the Abbott MitraClip, to see which one works better. Patients in this study are those who have a high risk from surgery or are already on special heart medicines, called Guideline Directed Medical Therapy (GDMT).

To be part of the study, you must be at least 18 years old and willing to attend follow-up visits after the procedure at discharge, 30 days, 6 months, and yearly for 5 years.

  • Visits: After your initial procedure, you will have follow-ups for up to 5 years.
  • Eligibility: You need to be at high risk for surgery or on specific heart medications.
  • Risks: You cannot join if you have certain heart problems or other severe health issues.

Make sure you discuss with your doctor to know if joining this study is right for you.

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Study details
    Degenerative Mitral Valve Disease
    Mitral Regurgitation
    Mitral Insufficiency
    Functional Mitral Regurgitation

NCT03706833

Edwards Lifesciences

31 March 2025

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What is a clinical trial?

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

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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