About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
Untreated clinically significant coronary artery disease requiring revascularization
CABG, PCI, or TAVR within the prior 30 d
Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
Trial design
Treatments tested in this trial
- MitraClip
- Moderate MR