New heart valve implant aims to fix leaky mitral valve without open surgery
NCT ID NCT04818502
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a device called the Tendyne mitral valve system in 200 people with mitral regurgitation, a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward. The valve is implanted through a tube in an artery, avoiding open-heart surgery. The main goal is to see if the valve stops the leak one year after the procedure.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Tendyne Mitral Valve System (a replacement heart valve implanted via a tube in an artery)
- What this could lead to
- If successful, this could provide a less invasive option for people with leaky mitral valves, potentially avoiding open-heart surgery.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be less definitive. Risks include procedural complications, valve blockage, or the need for additional procedures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for MITRAL REGURGITATION are added.
By submitting, you agree to our Terms of use
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
Locations
-
AOU Civili Brescia
Brescia, Italy
-
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
-
Bordeaux University Hospital
Bordeaux, France
-
CHRU de Lille
Lille, France
-
Clinico San Carlos
Madrid, Spain
-
Clinique Pasteur
Toulouse, France
-
German Heart Center Berlin
Berlin, Germany
-
German Heart Center Munich
Munich, Germany
-
Heart and Diabetes Center NRW
Bad Oeynhausen, Germany
-
Hospital AGEL Trinec-Podlesi
Třinec, Czechia
-
IKEM Prague
Prague, Czechia
-
Insel Bern
Bern, Switzerland
-
Kepler University Hospital
Linz, Austria
-
King Fahad Armed Forces
Jeddah, Saudi Arabia
-
King Fahad Medical City
Riyadh, Saudi Arabia
-
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia
-
Lancisi Cardiovascular Center - Politechnic University of Marcher
Ancona, Italy
-
Leipzig Heart Center
Leipzig, Germany
-
Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern
München, Germany
-
Lyon University Hospital
Lyon, France
-
MUMC+
Maastricht, Netherlands
-
Oslo University Hospital
Oslo, Norway
-
Rennes University Hospital
Rennes, France
-
Robert-Bosch Krankenhaus
Stuttgart, Germany
-
Royal Brompton Hospital
London, United Kingdom
-
Shaare Zedek Jerusalem
Jerusalem, Israel
-
Sheba Medical Centre
Tel Aviv, Israel
-
UZ Gasthuisberg
Leuven, Belgium
-
University Heart Center Hamburg
Hamburg, Germany
-
University Hospital Basel, Clinic for Cardiac Surgery
Basel, Switzerland
-
University Hospital Bonn
Bonn, Germany
-
University Hospital Frankfurt
Frankfurt, Germany
-
University Hospital Olomouc
Olomouc, Czechia
-
University Medical Center Mainz
Mainz, Germany
-
Universitätsclinic Cologne
Cologne, Germany
-
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- AI ultrasound could unmask silent heart disease in seniors
- Can a new valve device fix a leaky heart without open surgery?
- Can mixed reality make heart valve surgery safer and faster?
- A painless, contact-free vibration sensor may detect hidden heart and lung problems
- Can a Stick-On AI patch replace wires for heart monitoring after surgery?
- A new heart valve without open surgery? a trial puts it to the test