💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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