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

Launched by INOVA HEALTH CARE SERVICES · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help patients with heart failure and a condition called secondary mitral regurgitation, which means that the heart's mitral valve isn't closing properly. The goal is to see how effective the Inova Heart Failure Treatment Algorithm is in identifying patients who could benefit from a specific repair procedure using a device called the Mitraclip. This research will help doctors understand which patients are most likely to improve after this treatment.

To join the trial, participants need to be adults aged 18 and older with certain heart-related issues, like significant mitral regurgitation and reduced heart function. They should not be candidates for surgery and must have already received standard treatments for their heart conditions. If eligible, participants can expect to be randomly assigned to either receive the Mitraclip repair or to a control group for comparison. The trial is currently recruiting, and anyone interested should be ready to commit to follow-up visits and provide informed consent. This study aims to improve care for heart failure patients, so their participation could help shape future treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • Cerebrovascular accident within prior 30 d
• • Severe symptomatic carotid stenosis (N70% by ultrasound)
• • Carotid surgery or stenting within prior 30 d
• • ACC/AHA stage D HF
• * Presence of any of the following:
• • 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
• • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing HF other than dilated cardiomyopathy of either ischemic or nonischemic etiology
• • Infiltrative cardiomyopathies (eg, amyloidosis, hemochromatosis, sarcoidosis)
• • Hemodynamic instability requiring inotropic support or mechanical heart assistance
• • Physical evidence of right-sided congestive HF with echocardiographic evidence of moderate or severe right ventricular dysfunction
• • Implant of CRT or CRT-D within the last 30 d
• • 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
• • 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
• • Modified Rankin Scale ≥4 disability
• • 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
• • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• • Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (ie, noncompliant, perforated)
• • Active infections requiring current antibiotic therapy
• • TEE is contraindicated or high risk
• • Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
• • Pregnant or planning pregnancy within next 12m
• • Currently participating in an investigational drug or another device study that has not reached its primary end point
• • 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.