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New catheter device aims to fix leaky heart valves without open surgery

NCT ID NCT04919980

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a new device called the INNOVALVE system for people with a leaky mitral valve who are too high-risk for open-heart surgery. The device is delivered through a catheter to repair the valve. Researchers will check if it is safe and works well in 65 participants over 30 days.

What this could mean

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

Active substance
INNOVALVE system (a device implanted via catheter to repair the mitral valve)
What this could lead to
If it works, this could offer a less invasive treatment option for people with leaky mitral valves who cannot undergo open-heart surgery.
What could go wrong
This is an early feasibility study with only 65 participants, so results may not apply broadly. The device could cause serious side effects or fail to improve symptoms.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Clinically significant, symptomatic mitral regurgitation * High risk for open-heart surgery * Meets anatomical criteria Exclusion Criteria: * Unsuitable anatomy * Patient is inoperable * EF\<25%

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

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

Mitral valve regurgitation (degenerative or functional)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ascension Saint Thomas

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Cedars-Sinai

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cornell

    WITHDRAWN

    New York, New York, 10021, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 555905, United States

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Naples Comprehensive Health

    RECRUITING

    Naples, Florida, 34102, United States

  • NewYork-Presbyterian / Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Northwell Health

    RECRUITING

    Manhasset, New York, 11030, United States

  • Northwestern

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • OhioHealth Research Institute

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Oregon Health & Science Universtiy

    RECRUITING

    Portland, Oregon, 97239, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Saint Luke's Hospital

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94305, United States

  • Swedish Medical Center

    RECRUITING

    Seattle, Washington, 98122, United States

  • University of Michigan Hospital and Health Systems

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.