New heart valve replacement could spare patients from major surgery
NCT ID NCT05797519
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 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.
Disclaimer
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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.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
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Locations
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AZ Sint Jan Hospital
RECRUITINGBruges, Belgium
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Flinders Medical Centre
RECRUITINGAdelaide, Australia
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Contact
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Herz & Diabeteszentrum Nordrhein Westfalen
RECRUITINGBad Oeynhausen, Germany
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Hospital Clínico San Carlos
RECRUITINGMadrid, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital Universitario Puerta de Hierro
RECRUITINGMadrid, 28222, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Johannes Kepler University Linz - JKU
RECRUITINGLinz, Austria
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Contact Email: •••••@•••••
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Lund University Skåne University Hospital
RECRUITINGLund, Sweden
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Monash Heart
RECRUITINGMelbourne, Australia
Contact Email: •••••@•••••
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Nemocnice AGEL Podlesi Trinec
RECRUITINGTřinec, Czechia
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Princess Alexandra Hospital
RECRUITINGBrisbane, Australia
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Royal Brompton Hospital
RECRUITINGLondon, United Kingdom
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Royal Sussex Hospital
RECRUITINGBrighton, Sussex, BN2 1ES, United Kingdom
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St Antonius Hospital
RECRUITINGNieuwegein, Netherlands
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St. Vincent Hospital
RECRUITINGSydney, New South Wales, 2010, Australia
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The Prince Charles Hospital
RECRUITINGBrisbane, Australia
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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University Hospital of Copenhagen
RECRUITINGCopenhagen, DK-2100, Denmark
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Universitätsklinik für Herzchirurgie Medizinische Universität Wien
RECRUITINGVienna, 1090, Austria
Contact Email: •••••@•••••
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Universitätsklinikum Schleswig-Holstein, Campus Kiel
RECRUITINGKiel, 24105, Germany
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Universitätsmedizin Rostock
RECRUITINGRostock, 18057, Germany
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Vivantes Klinik Am Urban
RECRUITINGBerlin, 10967, Germany
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Waikato Hospital
RECRUITINGHamilton, Hamilton, 3204, New Zealand
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••