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

NCT ID NCT06906926

Recruiting now Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

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.

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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

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