Exercise-Triggered heart valve leak targeted in new trial
NCT ID NCT07709208
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
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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
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About 246 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Department of Cardiology, Pneumology and Vascular Medicine University Hospital Düsseldorf
Düsseldorf, Germany
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Department of Internal Medicine I (KIM I) Division of Cardiology, Angiology and Intensive Medical Care Jena University Hospital
Jena, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a dedicated heart failure network improve outcomes after hospitalization?