In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm

Prior treatment

• CABG, PCI, or TAVR within the prior 30 d
• COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
• Cerebrovascular accident within prior 30 d
• Carotid surgery or stenting within prior 30 d
• Implant of CRT or CRT-D within the last 30 d
• Status 1 heart transplant or prior orthotopic heart transplantation
• Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
• Currently participating in an investigational drug or another device study that has not reached its primary end point

Other illness

• Untreated clinically significant coronary artery disease requiring revascularization
• Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing HF other than dilated cardiomyopathy of either ischemic or nonischemic etiology
• Hemodynamic instability requiring inotropic support or mechanical heart assistance
• Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 m
• Life expectancy \<12 m due to noncardiac conditions
• Investigators opinion a condition that could limit the subject's participation
• Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (ie, noncompliant, perforated)
• Active infections requiring current antibiotic therapy
• Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
• Subject belongs to a vulnerable population or has any disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.

Lab values

• Estimated PASP N70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization laboratory is able to reduce the PVR to b3 Wood units or between 3 and 4.5 Wood units with v wave less than twice the mean of the PCWP

Other

• Severe symptomatic carotid stenosis (N70% by ultrasound)
• ACC/AHA stage D HF
• Presence of any of the following:
• Infiltrative cardiomyopathies (eg, amyloidosis, hemochromatosis, sarcoidosis)
• Physical evidence of right-sided congestive HF with echocardiographic evidence of moderate or severe right ventricular dysfunction
• Mitral valve orifice area \<4.0 cm2 by site-assessed TTE
• Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets, or sufficient reduction in MR by the MitraClip
• Hemodynamic instability defined as persistent systolic pressure \<90 mm Hg with or without afterload reduction, cardiogenic shock, or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• TEE is contraindicated or high risk
• Pregnant or planning pregnancy within next 12m

• Symptomatic MR (≥2+) due to cardiomyopathy of either ischemic or nonischemic etiology
• Subject has been adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, MR, and HF.
• NYHA functional class II, III, or ambulatory IV
• Local heart team has determined that MV surgery will not be offered as a treatment option even if the subject is randomized to the Control group.
• LVEF ≤50%.
• LVESD ≤70 mm
• The primary regurgitant jet , in the opinion of the MitraClip implanting investigator, can be successfully treated by the MitraClip (if a secondary jet exists, it must be considered clinically insignificant).
• Transseptal catheterization and femoral vein access is feasible per the MitraClip implanting investigator.
• Age 18 y or older
• Subject or guardian agrees to all provisions of the protocol
• NT-proBNP≥ 1500ng/ml or BNP≥ 300ng/ml