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New catheter device aims to fix leaky heart valve without cutting chest

NCT ID NCT03745313

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This early study tested a device called the Edwards PASCAL system, which is threaded through a blood vessel to repair the tricuspid valve in the heart. The valve can leak, causing symptoms like shortness of breath and swelling. The study included 65 people with severe leakage who were still having symptoms despite medication. The goal was to see if the device is safe and works well enough to improve their condition.

What this could mean

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

Active substance
Edwards PASCAL Transcatheter Valve Repair System (a device implanted via a catheter to repair the tricuspid valve)
What this could lead to
If successful, this device could offer a less invasive treatment option for people with severe tricuspid regurgitation who are not candidates for open-heart surgery.
What could go wrong
This is an early feasibility study with only 65 participants, so results may not apply to everyone. Risks include serious bleeding, stroke, or need for further procedures.

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

65 people

The number who actually took part.

Started

Feb 2019

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: * Severe functional or degenerative TR * Symptomatic despite medical therapy * The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair Exclusion Criteria: * Unsuitable anatomy * Previous tricuspid valve repair or replacement * Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease tricuspid valve insufficiency

As listed by the trial registrant

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

Tricuspid regurgitation

Contacts and locations

Locations

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290, United States

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

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