Status:
TERMINATED
Feasibility Study of Radiofrequency Heating of Cardiac Infarction Scar to Treat Heart Failure
Lead Sponsor:
CoRepair, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to examine the safety and potential effectiveness of a new surgical procedure for treating heart failure. The experimental treatment is performed during standard coronary ...
Detailed Description
Heart failure is an important health-care problem, resulting in significant numbers of patients, hospitalizations, and economic costs. The etiology of heart failure is coronary artery disease in appro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00881777
Start Date
September 1 2009
End Date
March 1 2011
Last Update
July 14 2011
Active Locations (3)
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1
Sanatorio Italiano
Asunción, Paraguay
2
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, Poland, 04-628
3
Silesian Center for Heart Diseases
Zabrze, Poland, 41-800