Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New heart valve study aims to improve lives of heart defect patients

NCT ID NCT05077774

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well the Harmony Transcatheter Pulmonary Valve (TPV) works when used by doctors in everyday practice. It involves 174 people with congenital heart disease who need a new pulmonary valve. The main goal is to see if the valve works properly without needing another procedure within six months.

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

174 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Mar 2035

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: * Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment * Patient (or patient's legally authorized representative) is willing to consent to participate in the study Exclusion Criteria: * Obstruction of the central veins * Planned concomitant branch pulmonary artery stenting at time of implant * Subject is pregnant at time of implant procedure * Patients with previously treated with an RV-PA conduit or previously implanted bioprosthesis * 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 * Planned implantation of the Harmony TPV in the left heart * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation * Pre-existing prosthetic heart valve or prosthetic ring in any position

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Congenital heart disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

congenital heart disease pulmonary valve insufficiency tetralogy of fallot

As listed by the trial registrant

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

Congenital heart disease Pulmonary regurgitation Rvot anomaly Tetrology of fallot

Contacts and locations

Locations

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453, United States

  • Atrium Health Levine Children's Hospital

    Charlotte, North Carolina, 28203, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Children's Hospital & Medical Center

    Omaha, Nebraska, 68114, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital New York - Presbyterian

    New York, New York, 10032, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Medical City Children's Hospital

    Dallas, Texas, 75230, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Saint Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • St. Joseph Children's Hospital

    Tampa, Florida, 33607, United States

  • The Mount Sinai Hospital

    New York, New York, 10029, United States

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35233, United States

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

More trials for these conditions

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