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

NCT ID NCT06906926

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Azienda Ospedaliera di Padova

    NOT_YET_RECRUITING

    Padova, Italy

    Contact Email: •••••@•••••

  • CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque

    RECRUITING

    Bordeaux, 33600, France

    Contact Email: •••••@•••••

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 12203, Germany

    Contact Email: •••••@•••••

  • Helios Health Institute Standort Leipzig

    RECRUITING

    Leipzig, 04289, Germany

    Contact Email: •••••@•••••

  • Herz - und Diabeteszentrum NRW

    RECRUITING

    Bad Oeynhausen, Germany

    Contact Email: •••••@•••••

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, 28007, Spain

    Contact Email: •••••@•••••

  • Mater Misericordiae University Hospital

    RECRUITING

    Dublin, 7, Ireland

    Contact Email: •••••@•••••

  • Policlinico di Sant'Orsola

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

    Contact Email: •••••@•••••

  • Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

    Contact Email: •••••@•••••

  • Schneider Children's Medical Center Israel

    RECRUITING

    Petah Tikva, 49202, Israel

    Contact Email: •••••@•••••

  • Skånes Universitetssjukhus Lund

    RECRUITING

    Lund, 22185, Sweden

    Contact Email: •••••@•••••

  • TUM University Hospital

    RECRUITING

    Munich, Germany

    Contact Email: •••••@•••••