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8110 Gatehouse Road, Falls Church, VA 22042

Abbott ICAIRE Best Practices for Patients with Heart Failure and Secondary MR: An

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General Information

Age Group

Adults

Status

Active

Protocol Number

N/A

Background Information

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 Mitral Regurgitation (MR).

The Inova Heart Failure Treatment Algorithm (IHFTA) combines the expertise of both interventional cardiology and heart failure specialists in a manner similar to that mandated in the COAPT trial. However, with IHFTA best practices are distilled into an easy to follow treatment algorithm that can be readily implemented in practices lacking heart failure specialists. From the following research protocol, we plan to:

  1. Determine the feasibility of the Inova IHFTA and its effectiveness in identifying patients who are most likely to benefit from percutaneous transcatheter mitraclip repair;
  2. Examine the therapeutic effectiveness of the iIHFTA and MitraClip therapy in treating secondary MR in a “real world” clinical practice by evaluating for reductions in MR, improvements in patient symptoms, functional status and QOL; and
  3. Determine if the IHFTA results in optimization of GDMT comparable to that noted in COAPT and within current Heart Failure Society of America (HFSA) recommendations.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Wayne Batchelor, MD

Eligibility Information

  • 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 years 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 post-procedure follow-up visits, and has provided written informed consent

Ineligibility Information

  • 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:
    • 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 (e.g., amyloidosis, hemochromatosis, sarcoidosis)
  • 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
  • Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets, or sufficient reduction in MR by the MitraClip
  • 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
  • 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 (i.e., 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 12 m
  • 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.