In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm
The overarching goal of this research proposal is to study the feasibility and clinical impact of implementing an Inova system-wide heart failure treatment algorithm for patients with symptomatic heart failure due to reduced left ventricular ejection fraction (HFreF) and secondary MR Aim is to check the effectiveness of the IHFTA in identifying patients who are most likely to benefit from percutaneous transcatheter Mitraclip repair in real world
• 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, including the possibility of randomization to the Control group and returning for all required postprocedure follow-up visits, and has provided written informed consent