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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Join our study on a new heart valve treatment option.

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

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial is a study to test a device called the Edwards PASCAL Transcatheter Valve Repair System. It helps fix the heart's mitral valve in patients with two types of mitral regurgitation (MR), where blood leaks backward in the heart. People with degenerative mitral regurgitation (DMR) can't have regular surgery, and those with functional mitral regurgitation (FMR) are on special heart medicines. The study compares this device to another device called MitraClip.

Participants will have follow-up visits after the procedure at 30 days, 6 months, and then every year for 5 years.

  • This study requires long-term follow-up visits for up to 5 years.
  • Participants must be 18 or older and willing to follow study guidelines.
  • Certain heart conditions or recent surgeries can exclude you from participation.

If you're interested, you should talk to your doctor to see if you qualify and understand any risks involved. They will help decide if this study is a good choice for you.

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

NCT03706833

Edwards Lifesciences

8 March 2025

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Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

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.

How long does a clinical trial take place?

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

Do I get compensated for taking part in clinical trials?

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

How safe are clinical trials?

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