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New heart valve study aims to fix leaky valve without Open-Heart surgery

NCT ID NCT06906926

Disease control Sponsor: Medtronic Cardiovascular 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Updated 2 times

Summary

This study is tracking 80 people with severe pulmonary valve regurgitation (a leaky heart valve) who receive the Harmony Transcatheter Pulmonary Valve. The valve is placed through a catheter, avoiding open-heart surgery. Researchers will check if the valve works well and stays in place at 6 months, and track survival and need for repeat procedures.

What this could mean

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

Active substance
Harmony Transcatheter Pulmonary Valve (TPV) System
What this could lead to
If successful, this could confirm that the Harmony valve is a safe and effective option for replacing a leaky pulmonary valve without open-heart surgery.
What could go wrong
This is a post-market study, not a new treatment test. It is small (80 people) and observational, so results may not apply to everyone. Risks include valve failure or need for reintervention.

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 80 people

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

Started

Jul 2025

Expected to finish

Dec 2032

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Subject eligible to receive Harmony TPV System in conformity with Instructions for Use (IFU) and local regulations at time of study enrollment. 2. Subject or subject's parent(s)/legal guardian(s) must be willing and able to consent to participate in the study and will commit to completion of all follow-up requirements Exclusion Criteria: 1. Obstruction of the central veins. 2. Planned concomitant branch pulmonary artery stenting at time of implant. 3. Subjects previously treated with an RV-PA conduit or previously implanted bioprosthesis. 4. A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year. 5. Planned implantation of the Harmony TPV in the left heart. 6. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 7. Pre-existing prosthetic heart valve or prosthetic ring in any position 8. Subject is pregnant as confirmed by a positive pregnancy test before implant procedure for female subjects of childbearing potential. 9. Subjects that are vulnerable as defined in the Section 10.5 Subject Consent Subject Consent Section excerpt: * Vulnerable adults, defined as subjects incapable of giving consent, as assessed per Investigator's opinion and in consideration of vulnerable adult definition per ISO 14155, will not be included in this study. * Any subject with mental incompetence (e.g. Alzheimer's, dementia, psychiatric disorders, developmental disorders, chromosomal abnormalities with associated cognitive impairment) should be assessed by the Investigator for vulnerable status. If pediatric or adult subject is deemed by the Investigator mentally incompetent as described above, the subject will not be included in this study.

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Conditions

The condition(s) this trial relates to.

pulmonary valve insufficiency

As listed by the trial registrant

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

Severe pulmonary valve regurgitation

How to take part

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

  1. The places running it

    12 sites in 8 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Azienda Ospedaliera di Padova

    NOT_YET_RECRUITING

    Padova, Italy

  • CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque

    RECRUITING

    Bordeaux, 33600, France

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 12203, Germany

  • Helios Health Institute Standort Leipzig

    RECRUITING

    Leipzig, 04289, Germany

  • Herz - und Diabeteszentrum NRW

    RECRUITING

    Bad Oeynhausen, Germany

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, 28007, Spain

  • Mater Misericordiae University Hospital

    RECRUITING

    Dublin, 7, Ireland

  • Policlinico di Sant'Orsola

    RECRUITING

    Bologna, 40138, Italy

  • Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

  • Schneider Children's Medical Center Israel

    RECRUITING

    Petah Tikva, 49202, Israel

  • Skånes Universitetssjukhus Lund

    RECRUITING

    Lund, 22185, Sweden

  • TUM University Hospital

    RECRUITING

    Munich, Germany