New heart valve replacement could spare patients from major surgery

NCT ID NCT05797519

Recruiting now Disease control Sponsor: VDyne, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study tests a new device called the VDyne System, which is placed through a tube in a blood vessel to replace the tricuspid valve in the heart. It is for people with severe tricuspid regurgitation, a condition where the valve does not close properly, causing blood to leak backward. The trial will enroll 120 participants to see if the device is safe and effective at reducing leakage, improving symptoms, and enhancing quality of life.

What this could mean

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

Active substance: VDyne transcatheter tricuspid valve replacement system (a device implanted via a tube to replace the leaky valve)
What this could lead to: If it works, this could offer a less invasive treatment option for people with severe tricuspid regurgitation who cannot have open-heart surgery.
What could go wrong: This is an early-stage study with only 120 participants, so results may not apply to everyone. The procedure carries risks like bleeding, infection, or device complications.

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.

tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

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

TRICUSPID REGURGITATION TRICUSPID VALVE DISEASE TRICUSPID VALVULAR DISORDERS

Contacts and locations

Locations

AZ Sint Jan Hospital
RECRUITING

Bruges, Belgium
Flinders Medical Centre
RECRUITING

Adelaide, Australia
Herz & Diabeteszentrum Nordrhein Westfalen
RECRUITING

Bad Oeynhausen, Germany
Hospital Clínico San Carlos
RECRUITING

Madrid, Spain
Hospital Universitario Puerta de Hierro
WITHDRAWN

Madrid, 28222, Spain
Johannes Kepler University Linz - JKU
RECRUITING

Linz, Austria
Lund University Skåne University Hospital
WITHDRAWN

Lund, Sweden
Monash Heart
RECRUITING

Melbourne, Australia
Nemocnice AGEL Podlesi Trinec
RECRUITING

Třinec, Czechia
Princess Alexandra Hospital
RECRUITING

Brisbane, Australia
Royal Brompton Hospital
WITHDRAWN

London, United Kingdom
Royal Sussex Hospital
RECRUITING

Brighton, Sussex, BN2 1ES, United Kingdom
St Antonius Hospital
WITHDRAWN

Nieuwegein, Netherlands
St. Vincent Hospital
RECRUITING

Sydney, New South Wales, 2010, Australia
The Prince Charles Hospital
RECRUITING

Brisbane, Australia
University Hospital of Copenhagen
WITHDRAWN

Copenhagen, DK-2100, Denmark
Universitätsklinik für Herzchirurgie Medizinische Universität Wien
WITHDRAWN

Vienna, 1090, Austria
Universitätsklinikum Schleswig-Holstein, Campus Kiel
RECRUITING

Kiel, 24105, Germany
Universitätsmedizin Rostock
RECRUITING

Rostock, 18057, Germany
Vivantes Klinik Am Urban
RECRUITING

Berlin, 10967, Germany
Waikato Hospital
ACTIVE_NOT_RECRUITING

Hamilton, Hamilton, 3204, New Zealand

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