Feasibility Study of Radiofrequency Heating of Cardiac Infarction Scar to Treat Heart Failure (RECOVER)

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Cardiomyopathy, Ventricular Dysfunction, Heart Disease Read More

Inclusion Criteria:

• Age 18 to 80 years, inclusive
• Symptomatic heart failure (defined as persistent NYHA class II or III during the 3 months prior to enrollment)
• On evidence-based medical therapy for heart failure during the 1 month prior to enrollment
• Referred for elective coronary artery bypass grafting
• Dyskinetic transmural myocardial infarct located in the apical portion of the anterior, lateral, and/or inferior left ventricular wall as determined by transthoracic echocardiography ("transmural" means end-diastolic wall thickness of 4 - 6 mm, inclusive)
• Left ventricular ejection fraction 20 - 45%, inclusive as determined by transthoracic echocardiography
• Left ventricular end-systolic volume index ≥ 60 ml/m2 as determined by transthoracic echocardiography
• 6-minute walk distance over 150 m
• Peak VO2 (ml/kg/min): 10.0 - 20.0 for males and 9.0 - 18.0 for females

Exclusion Criteria:

• Myocardial infarction ≤ 3 months prior to enrollment
• Evidence of calcification within the scar intended to be treated by any imaging modality
• Presence of a coronary stent within the scar intended to be treated
• Evidence of left ventricular thrombus
• Emergent cardiac surgery
• Percutaneous coronary intervention (PCI) ≤ 1 month prior to enrollment or planned following enrollment
• Only for patients undergoing MR (rather than CT) imaging: Contraindications for MRI (current or anticipated during the 6 months following enrollment), such as pacemaker, Automatic Implantable Cardioverter-Defibrillator (AICD), Cardiac Resynchronization Therapy (CRT) device, central nervous system aneurysm clips, Cochlear implant, or metal shrapnel
• Only for patients undergoing MR (rather than CT) imaging: Acute or chronic severe renal insufficiency (i.e. a glomerular filtration rate < 30 ml/min/1.73m2) or acute renal insufficiency of any severity due to hepato-renal syndrome
• Only for patients undergoing MR (rather than CT) imaging: Known allergy or reaction to Gadolinium
• Atrial fibrillation
• Prior cardiac surgery (including coronary artery bypass grafting, valve replacement or repair, aortic root replacement) or anticipated during the 6 months following enrollment
• Major non-cardiac surgery (e.g. knee or hip replacement, laparotomy, carotid endarterectomy, etc.) ≤ 3 months prior to enrollment or planned during the 6 months following enrollment
• Prior heart, kidney, liver, or lung transplantation
• Valvular heart disease requiring replacement or repair (e.g. mitral valve regurgitation ≥ 3+)
• Cardiogenic shock ≤ 72 hours prior to the CABG surgery (defined as need for Intra-Aortic Balloon Pump or requiring intravenous inotropic support)
• Currently needing (or anticipated need for) Left Ventricular Assist Device or other cardiac replacement device
• On active heart transplant list or anticipated need for transplant during the 6 months following enrollment
• Stoke or transient ischemic attack ≤ 3 months prior to enrollment
• Chronic dialysis
• Major infection or sepsis ≤ 72 hours of enrollment (defined as requiring IV antibiotics for > 3 days)
• Endocarditis, myocarditis, or pericarditis
• Co-morbid condition that, in the investigator's opinion, results in the patient's life expectancy being < 180 days
• Evidence of significant blood chemistry abnormalities, including creatinine > 2.5 mg/dl, BUN ≥ 100 mg/dl, liver function tests > 3 times upper limit of normal, Hgb < 10 gm/dl, HCT < 25%, platelet count < 100,000/mm3, or white blood cell count < 3,000/mm3 or > 20,000/mm3
• Females of child-bearing potential without a documented negative pregnancy test within the 14 days prior to enrollment (and prior to the MRI or CT) or who are unwilling to use effective contraception for the duration of this study
• Participation in another investigational device or drug trial
• Unable or unwilling to give Informed Consent
• Unwilling or unlikely to complete the required follow-up
• Any other medical condition that, in the judgment of the investigator, would cause this study to be detrimental to the patient