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New No-Scalpel heart valve offers hope for leaky hearts

NCT ID NCT02979587

Disease control Sponsor: Medtronic Heart Valves 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing a new type of heart valve called the Harmony TPV, which is placed using a thin tube (catheter) instead of open-heart surgery. It is for people with congenital heart disease who have a leaky pulmonary valve. The study will check if the valve works well and is safe over time, including how well it controls blood flow and whether it causes serious problems. About 86 participants are being followed long-term.

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 (a replacement heart valve made from pig tissue and metal frame, delivered through a catheter)
What this could lead to
If successful, this could provide a less invasive option for replacing a leaky pulmonary valve, avoiding open-heart surgery for many patients with congenital heart disease.
What could go wrong
This is a post-approval study with a small number of participants (86). The valve may not fit all anatomies, and long-term durability or complications like valve failure or blood clots remain possible.

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

86 people

The number who actually took part.

Started

Jan 2017

Expected to finish

Feb 2031

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: * Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR determined PR fraction \>/= 30% * Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve * Subject is willing to consent to participate Exclusion Criteria: * Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-to-PA conduit implant * RVOT anatomy or morphology that is unfavorable for device anchoring * Positive pregnancy test * Life expectancy of less than 1 year

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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

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • National Cerebral and Cardiovascular Center

    Suita, Osaka, 565-8565, Japan

  • Nationwide Children's Hospital

    Columbus, Ohio, 43215, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Ronald Regan UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Stanford University Medical Center

    Palo Alto, California, 94304, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • The Hospital for Sick Children (SickKids)

    Toronto, Ontario, M5G 1X8, Canada

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • Yale University

    New Haven, Connecticut, 06510, United States

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