Mitral Insufficiency Reduction With Biventricular Pacing (MiRBi)

Inclusion Criteria:

• Patient is at least 18 years of age

• Patients with moderate-to-severe or severe functional MR.

  • EROA > 40 mm2 and an MR/LA > 40% (severe)
  • 30 ≤ EROA ≤ 40 mm2 and 30 ≤ MR/LA ≤ 40% (moderate-to-severe)
• Baseline rates of 50-90 beats per minute (patients with sinus rhythm) or AF
• QRS < 120 ms
• LVEF < 35%
• Willing to sign informed consent
• On standard stable heart failure medical regimen (beta blockers and ACE-I or ARBs) for at least 1 month before randomization, if tolerated
• Patient has the ability to understand the requirements of the study, including consent for use and disclosure of research-related information
• Patient has the ability to comply with study procedures and protocol, including required study visits

Exclusion Criteria:

• candidate for CRT or has a previously implanted CRT device
• previously implanted implantable pulse generators (IPG) or implantable cardioverter defibrillator (ICD) with at least 10 % pacing in the right ventricle
• patient has life expectancy <6 months
• patient is pregnant
• significant aortic stenosis
• uncontrolled hypertension
• mitral valve stenosis
• severe mitral valve calcification
• ruptured chordae tendinae or papillary muscle
• mitral valve leaflet disorders (i.e. endocarditis, lupus, tumors, rheumatic heart disease)
• chronic mitral leaflet degeneration (ie. Marfans)
• previous valve replacement or surgery
• IV inotropes or IV vasodilators
• candidate for mitral valve repair or replacement surgery within the next 6 months
• patient has in-hospital acute coronary syndrome (ACS) (NSTEMI/STEMI) prior to randomization
• patient has planned or elective percutaneous coronary intervention (PCI) or other non-cardiac surgery prior to randomization
• patient is currently enrolled in an investigational drug or device study
• patient is clinically unstable per PI assessment