Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation

Prior treatment

• Evidence of transient ischemic attack or stroke within three months prior to intervention
• 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

Other illness

• Hospitalization in past three months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
• Subjects expected to require any cardiac surgery, including surgery for coronary artery disease or for pulmonic, aortic, or tricuspid valve disease within one year
• Severe right ventricular failure
• 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
• 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

Lab values

• LVEF \<20%
• Presence of primary renal dysfunction or significantly compromised renal function (eGFR \<30 ml/min)

Other

• LVEDD \>70 mm
• Percutaneous coronary intervention in the last 30 days
• Severe aortic stenosis (aortic valve area \<1.0 cm\^2) or aortic regurgitation
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• 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

• 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