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

Inova Health Care Services

Status: Enrolling

Conditions: Valvular Heart Disease; Mitral Regurgitation; Heart Failure

Treatments: Device: MitraClip; Other: Moderate MR

Study type: Observational

Funder types: Other

Identifiers

NCT06675448

U20-09-4258

Details and patient eligibility

About

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

Full description

All patients passing through the IHFTA will be tracked and followed w.r.t. their final therapies. Monthly meetings will occur with the IHFTA research team to assess and discuss any challenges in implementing the protocol. Impediments will be identified, and strategies put forth to address them. To examine whether the Inova IHFTA identifies the patient most likely to benefit from Mitraclip, the baseline clinical and echocardiographic characteristics of patients treated with Mitraclip within the IHFTA (who would have met the criteria for COAPT study) will be compared to those of the treated cohort in the COAPT trial using t-tests and Chi-squared tests

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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
• NT-proBNP≥ 1500ng/ml or BNP≥ 300ng/ml

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
• Investigators opinion a condition that could limit the subject's participation
• 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.

Trial design

50 participants in 2 patient groups

Moderate MR

Description:

Patients who present with moderate MR and remain in this state will be re-evaluated at 6 months by a phone call and EMR review for ConComitant Cardiac Medication Review, NYHA Class and Adverse Event Evaluation. At 12 months a follow-up evaluation that will include a review of medications, NYHA class, KCCQ, 6MWT, BNP, Adverse Event review and TTE.

Treatment:

Other: Moderate MR

Mitraclip

Description:

For patient who undergo Mitraclip, the safety and effectiveness of the procedure will be evaluated and all peri-procedural complications recorded using the same definitions for procedural success and complications used in the COAPT trial

Treatment:

Device: MitraClip