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.
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
The study population for this study include adult patients \> 18 years of age who have symptomatic (NYHA class II-IVa) HFreF due to ischemic or idiopathic dilated cardiomyopathy (LV ejection fraction ≤ 50%), moderate (2+) to severe (4+) secondary MR and either at least 1 HF hospitalization within the prior 12 months or an elevated brain natriuretic peptide (BNP≥300) or N-terminal pro b-type natriuretic peptide (NT-proBNP ≥ 1500) and have been determined by the site's local heart team as not being appropriate for MV surgery. This study population is similar to patients enrolled in COAPT, but includes patients who present with moderate 2+ MR and others who may end up needing only optimal GDMT and/or CRT or Cardiomems.
Case-control
Prospective
MitraClip
DeviceParticipants will undergo the Mitraclip procedure according to current standards of practice
Moderate MR
Other interventionPatients who present with moderate MR (Mitral regurgitation) will serve also as an internal control against which the outcomes of Mitraclip treated patients)
Change in NYHA from baseline to 6 months in patients who undergo Mitraclip
There are 4 levels of NYHA: I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).
Click on the lead sponsor to view all of their trials.
