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New heart valve device could spare High-Risk patients from Open-Heart surgery

NCT ID NCT03230747

Ongoing Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This trial tests a new device called the Edwards SAPIEN M3 System for people with severe mitral regurgitation, a condition where a heart valve leaks blood backward. The device is placed using a thin tube threaded through blood vessels, avoiding open-heart surgery. The study includes 72 patients who are at high risk for surgery and aims to see if the device can be safely and correctly implanted to reduce the leak.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
a device called the Edwards SAPIEN M3 System, which includes a replacement valve and a dock to hold it in place
What this could lead to
If successful, this could offer a less invasive treatment option for people with severe mitral regurgitation who are too high-risk for surgery.
What could go wrong
This is an early feasibility study with only 72 participants, so the device may not work as intended or could cause complications like improper placement or emergency surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

disease mitral valve disorder mitral valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MITRAL DISEASE MITRAL REGURGITATION

Contacts and locations

Locations

  • California Pacific Medical Center

    San Francisco, California, 94109, United States

  • Cedars-Sinai Medical Center Heart Institute

    Los Angeles, California, 90048, United States

  • Emory University

    Atlanta, Georgia, 30308, United States

  • Evanston/ Northshore University

    Evanston, Illinois, 60201, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Sentara Cardiovascular Research Institution

    Norfolk, Virginia, 23507, United States

  • St. Paul's Hospital

    Vancouver, British Columbia, V62146, Canada

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