Mitral Valve Edge-to-Edge Repair for exercise-induced severe mitral regurgitation in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study randomizes adults with heart failure and exercise-induced severe secondary mitral regurgitation to receive either guideline-directed medical therapy (GDMT) alone or GDMT plus transcatheter edge-to-edge repair (TEER). The goal is to determine if TEER improves clinical outcomes, reduces death or heart-failure hospitalizations, and enhances quality of life over 12 months. Eligibility requires mild-to-moderate SMR at rest that worsens with exercise and specific imaging/biomarker criteria, with a stable GDMT regimen prior to the procedure. Participants will undergo screening, randomization, and scheduled follow-ups to assess safety and efficacy. The study is sponsored by Jena University Hospital with collaboration at two European centers.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Christian Schulze, Prof. Dr.
• Email: christian.schulze@med.uni-jena.de
• Phone: +49 3641 9 324101

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.