New heart valve implant aims to fix leaky mitral valve without open surgery

NCT ID NCT04818502

Ongoing Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

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.

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.

heart valve disorder mitral valve insufficiency

As listed by the trial registrant

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

MITRAL VALVE REGURGITATION

Contacts and locations

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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