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New device could fix leaky heart valves without Open-Heart surgery

NCT ID NCT04614402

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This trial tests a device called the Edwards PASCAL system, which is used to repair a leaky tricuspid valve in the heart without open-heart surgery. The study includes 300 people with severe tricuspid regurgitation who are candidates for this procedure. Researchers are checking how safe and effective the device is by tracking complications and how much the valve leakage improves.

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 PASCAL Transcatheter Valve Repair System, which is threaded through a blood vessel to repair the tricuspid valve without open-heart surgery
What this could lead to
If successful, this could offer a less invasive treatment option for people with severe tricuspid regurgitation, potentially reducing symptoms and improving quality of life without the need for open-heart surgery.
What could go wrong
This is a post-market study, so the device is already approved, but it may still have risks like bleeding, infection, or the repair not lasting. The results may not apply to all patients with tricuspid regurgitation.

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.

Participants

About 300 people

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

Started

Jan 2021

Expected to finish

Mar 2028

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.

Who is studied

Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient tricuspid valve (TR ≥ 3+) by a Heart Team who assesses patient risk and anatomic suitability for the procedure.

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: 1. Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team 2. TR grade ≥3+ (5 grade classification) 3. Patient is eligible to receive the PASCAL device per the current approved indications for use Exclusion Criteria: 1. Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement 2. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation 3. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator 4. Any patient considered to be part of a vulnerable population

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Conditions

The condition(s) this trial relates to.

tricuspid valve insufficiency

As listed by the trial registrant

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

Tricuspid valve insufficiency

Contacts and locations

Locations

  • Heart Centre of the University Leipzig

    Leipzig, Saxony, 04289, Germany

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

  • Herzzentrum Universitätsklinikum Köln

    Cologne, DEU, D-50937, Germany

  • Herzzentrum der Universitätsklinik Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Hygeia Hospital

    Athens, 151 23, Greece

  • Inselspital

    Bern, 3010, Switzerland

  • Kath. Marienkrankenhaus Hamburg gGmbH

    Hamburg, 22087, Germany

  • Medizinische Klinik I- Campus Grosshadern

    München, Bavaria, 81377, Germany

  • Ospedale del Cuore "G. Pasquinucci"

    Massa, Italy

  • UKE Hamburg

    Hamburg, 20246, Germany

  • University Heart Center Lübeck

    Lübeck, Germany

  • Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsklinikum Ulm Innere Medizin II

    Ulm, Baden-Wurttemberg, 89070, Germany

  • Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie

    Essen, Nordrhine Westfalia, 45147, Germany

  • Zentralklinik Bad Berka GmbH

    Bad Berka, Thuringia, 99437, Germany

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