Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation (NCT07709208) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Germany246 participantsStarted 2026-08
Plain-language summary
The goal of this clinical trial is to learn whether mitral valve transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy (GDMT) can improve clinical outcomes and symptoms in heart failure patients with non-severe secondary mitral regurgitation (SMR) at rest and exercise-induced severe SMR.
The main questions it aims to answer are:
* Does mitral valve TEER in addition to GDMT lead to better overall clinical outcomes than GDMT alone in patients with heart failure and exercise-induced severe SMR?
* Does mitral valve TEER reduce the risk of death, heart failure hospitalization, or worsening SMR during 12 months of follow-up compared with GDMT alone?
* Does mitral valve TEER improve patients' quality of life compared with GDMT alone?
Participants will:
* Undergo screening assessments to confirm eligibility for the study.
* Be randomly assigned to receive either GDMT alone or GDMT plus mitral valve TEER.
* Attend follow-up visits at approximately 3 time points during a 12-month follow-up period.
* Undergo clinical evaluations that are routinely performed in patients with heart failure and SMR, including assessment of symptoms, functional status, and cardiac function.
The patients' echocardiographic data will undergo an additional centralized assessment by an independent Core Laboratory.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 failur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Four-step hierarchical composite primary endpoint; win ratio based on the following parameters: time to all-cause mortality at 12 months, time to first HF hospitalization, SMR progression (3+/4+) at rest, change in KCCQ score from baseline to 12 months.