Exercise-Triggered heart valve leak targeted in new trial

NCT ID NCT07709208

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This trial investigates whether a minimally invasive procedure called mitral valve TEER, added to standard medical therapy, improves outcomes for heart failure patients whose mitral valve leakage becomes severe only during exercise. Participants are randomly assigned to receive either medical therapy alone or medical therapy plus the TEER procedure. The study tracks deaths, heart failure hospitalizations, valve leakage progression, and quality of life over 12 months.

What this could mean

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

Active substance
Mitral valve transcatheter edge-to-edge repair (TEER) plus guideline-directed medical therapy
What this could lead to
If successful, this could establish a new treatment option for heart failure patients whose mitral regurgitation worsens only during exercise, potentially reducing hospitalizations and improving survival.
What could go wrong
This is a randomized trial, but the procedure carries risks such as bleeding, infection, or valve damage. The benefit may be small or limited to certain patients.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 246 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: * Mild-to-moderate (1+/2+) SMR at rest * Exacerbation of SMR to exercise-induced severe (3+/4+) SMR defined by at least one of the following: * 40 mm\^2 EROA (30 mm\^2 under low-flow condition) or * regurgitant volume ≥60 mL (45 mL under low-flow condition) or * regurgitant fraction ≥40% or * increase by 13 mm\^2 EROA from rest to exercise * Increase in natriuretic peptides defined as NT-proBNP: * \>250 pg/ml (Sinus rhythm) or * \>600 pg/ml (Atrial fibrillation) or * HF hospitalization within 12 months prior to screening (defined as HF listed as the major reason for hospitalization) * NYHA class II-IV * Stable HF medication regimen (GDMT) for at least 30 days prior to index procedure * Patient deemed appropriate candidate for TEER by the local multidisciplinary heart team * Age ≥ 18 years old * Written Informed consent Exclusion Criteria: * Hospitalization in past three months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina * LVEDD \>70 mm * LVEF \<20% * Evidence of transient ischemic attack or stroke within three months prior to intervention * Percutaneous coronary intervention in the last 30 days * Subjects expected to require any cardiac surgery, including surgery for coronary artery disease or for pulmonic, aortic, or tricuspid valve disease within one year * Presence of primary renal dysfunction or significantly compromised renal function (eGFR \<30 ml/min) * Severe right ventricular failure * Severe aortic stenosis (aortic valve area \<1.0 cm\^2) or aortic regurgitation * Hemodynamic instability requiring inotropic support or mechanical heart circulatory support * Presence of a mechanical mitral heart valve, mitral bioprosthetic valve or mitral annuloplasty ring, indication for cardiac resynchronization therapy * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation * Active endocarditis or infections requiring current antibiotic therapy * Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing HF other than SMR * Inability to exercise * Pregnancy or planning pregnancy within next12 months * Life expectancy \<12 months (judgement of investigator) * Anticipated need of left ventricular assist device within next 12 months * Participation in another interventional clinical trial (primary endpoint not yet reached) during this trial or within 30 days prior to enrolment into this trial * Previous participation in this trial

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Cardiology, Pneumology and Vascular Medicine University Hospital Düsseldorf

    Düsseldorf, Germany

  • Department of Internal Medicine I (KIM I) Division of Cardiology, Angiology and Intensive Medical Care Jena University Hospital

    Jena, Germany

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