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New catheter device offers hope for leaky heart valve patients

NCT ID NCT03170349

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

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new device called the Edwards PASCAL system, which repairs leaky mitral heart valves using a thin tube inserted through a blood vessel, avoiding open-heart surgery. It involved 124 adults with moderate-to-severe mitral regurgitation who were candidates for surgery. The goal was to see if the device safely reduces valve leakage and improves symptoms, with follow-up over one year.

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

124 people

The number who actually took part.

Started

Jun 2017

Finished

May 2025

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: * Signed and dated IRB/ethics committee approved study consent form prior to study related procedures * Eighteen (18) years of age or older * New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy * Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation * Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE). * The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant. * Mitral valve area (MVA) ≥ 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable. Exclusion Criteria: * Patient in whom a TEE is contraindicated or screening TEE is unsuccessful * Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation. * Mitral valve area (MVA) \< 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable) * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation * Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction * Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator * Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment * Patient is under guardianship

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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

Contacts and locations

Locations

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hygeia Hospital

    Athens, 15123, Greece

  • Inselspital, University Hospital Bern

    Bern, 3010, Switzerland

  • Metro North Hospital & Health Service, The Prince Charles Hospital

    Brisbane, Chermside, QLD 4032, Australia

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201, United States

  • San Rafaelle Hospital

    Milan, 20132, Italy

  • St Michael Hospital

    Toronto, Ontario, M5B-1W8, Canada

  • St. Paul's Hospital, Providence Health Care Research Institute

    Vancouver, British Columbia, V6E 1M7, Canada

  • Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5, Canada

  • Sydney Local Health District, Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie

    Bonn, 53127, Germany

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

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