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

NCT ID NCT04818502

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects of all genders from the population of patients meeting indications for a Tendyne implant as stated within the IFU. Subjects must meet all eligibility criteria and provide written informed consent.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use. 2. Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits. 3. Patient provides written informed consent prior to any study-specific procedure. Exclusion Criteria: 1. Patient is in another clinical study that may impact the follow-up or results of this study. 2. Patient is pregnant or nursing or plan to become pregnant during the study follow-up period. 3. Patient is under the age of 18 or age of legal consent. 4. Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.

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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

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.