Feasibility Study of Radiofrequency Heating of Cardiac Infarction Scar to Treat Heart Failure (RECOVER)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Radiofrequency heating of the myocardial infarct scar
Coronary Artery Bypass Grafting (CABG) surgery
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Cardiomyopathy, Ventricular Dysfunction, Heart Disease
Eligibility Criteria
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
Sites / Locations
- Sanatorio Italiano
- The Cardinal Stefan Wyszynski Institute of Cardiology
- Silesian Center for Heart Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RF Heating + CABG
CABG Alone
Arm Description
Radiofrequency heating of the myocardial infarct scar plus Coronary Artery Bypass Grafting (CABG) surgery
Coronary Artery Bypass Grafting (CABG) surgery only, without radiofrequency heating of the myocardial infarct scar
Outcomes
Primary Outcome Measures
Change in Left Ventricular End Diastolic and Systolic Volume Indexes as measured by Cardiac MRI/CT
Occurrence of any of the following: cardiac hemorrhage/rupture, cardiac tamponade, stroke/transient ischemic attack/renal failure, myocardial infarction, sepsis/cardiac-related infection, re-hospitalization for cardiac cause, or all-cause mortality
Secondary Outcome Measures
Change in Left Ventricular End Diastolic and Systolic Dimensions, Volumes, and Volume Indexes, and Left Ventricular Ejection Fraction as measured by Cardiac MRI/CT
Change in New York Heart Association Functional Classification and Canadian Cardiovascular Society Angina Grading Scale
Change in Cardiopulmonary Exercise Stress Test (Peak VO2 and VE/VCO2 slope)
Change in 6-Minute Walk distance
Change in Quality of Life Questionnaire score (Minnesota Living With Heart Failure and EuroQol EQ-5D)
Occurrence of individual primary safety endpoints, heart failure deaths, heart failure hospitalizations, all-cause hospitalizations, days alive out of the hospital, and neurological assessments (NIH Stroke Scale and Mini-Mental Status Exam)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00881777
Brief Title
Feasibility Study of Radiofrequency Heating of Cardiac Infarction Scar to Treat Heart Failure
Acronym
RECOVER
Official Title
Radiofrequency Energy Use in Cardiomyopathy and Ventricular Enlargement (RECOVER)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit suitable subjects within a reasonable time period.
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CoRepair, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 artery bypass graft (CABG) surgery, and applies radiofrequency energy to heat a portion of the damaged heart muscle. The tissue heating reduces the enlarged heart of patients suffering from ischemic heart failure, and may result in the heart pumping blood more efficiently, thereby improving the functional status of the patient.
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 approximately two-thirds of cases, and the majority of these patients have experienced prior myocardial infarction. As a consequence of the myocardial infarction, the ventricle undergoes changes in volume and shape, a process referred to as "ventricular remodeling". As the left ventricle enlarges, global systolic function worsens, resulting in heart failure. There are a number of treatment options available to minimize symptoms and somewhat slow disease progression. Unfortunately, even with best conventional drug and device therapies, heart failure patients continue to have high morbidity and mortality rates. The experimental therapy investigated in this study uses a surgical device which employs radiofrequency energy to heat epicardial tissue. The application of heat to a myocardial infarction scar causes it to shrink in size, and correspondingly reduces ventricular volume. The volume reduction may "reverse remodel" the enlarged and dysfunctioning left ventricle to a more normal size and shape. The intent of this clinical study is to evaluate whether radiofrequency heating of the myocardial infarct scar is safe, and determine if the resulting ventricular volume reduction translates into improved clinical and functional outcomes in patients suffering from ischemic heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Cardiomyopathy, Ventricular Dysfunction, Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RF Heating + CABG
Arm Type
Experimental
Arm Description
Radiofrequency heating of the myocardial infarct scar plus Coronary Artery Bypass Grafting (CABG) surgery
Arm Title
CABG Alone
Arm Type
Active Comparator
Arm Description
Coronary Artery Bypass Grafting (CABG) surgery only, without radiofrequency heating of the myocardial infarct scar
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency heating of the myocardial infarct scar
Intervention Description
Radiofrequency energy is applied to the epicardial surface of the heart using an external generator and a hand-held probe to heat myocardial infarction scar.
Intervention Type
Procedure
Intervention Name(s)
Coronary Artery Bypass Grafting (CABG) surgery
Intervention Description
A standard surgical procedure performed to relieve angina and reduce the risk of death from coronary artery disease. Arteries or veins from elsewhere in the body are grafted to the coronary arteries to bypass atherosclerotic narrowings and improve the blood supply to the coronary circulation supplying the myocardium.
Primary Outcome Measure Information:
Title
Change in Left Ventricular End Diastolic and Systolic Volume Indexes as measured by Cardiac MRI/CT
Time Frame
6 Months
Title
Occurrence of any of the following: cardiac hemorrhage/rupture, cardiac tamponade, stroke/transient ischemic attack/renal failure, myocardial infarction, sepsis/cardiac-related infection, re-hospitalization for cardiac cause, or all-cause mortality
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Left Ventricular End Diastolic and Systolic Dimensions, Volumes, and Volume Indexes, and Left Ventricular Ejection Fraction as measured by Cardiac MRI/CT
Time Frame
Peri-operative, 6 and 12 months
Title
Change in New York Heart Association Functional Classification and Canadian Cardiovascular Society Angina Grading Scale
Time Frame
1, 3, 6, and 12 months
Title
Change in Cardiopulmonary Exercise Stress Test (Peak VO2 and VE/VCO2 slope)
Time Frame
6 and 12 months
Title
Change in 6-Minute Walk distance
Time Frame
1, 3, 6, and 12 months
Title
Change in Quality of Life Questionnaire score (Minnesota Living With Heart Failure and EuroQol EQ-5D)
Time Frame
1, 3, 6, and 12 months
Title
Occurrence of individual primary safety endpoints, heart failure deaths, heart failure hospitalizations, all-cause hospitalizations, days alive out of the hospital, and neurological assessments (NIH Stroke Scale and Mini-Mental Status Exam)
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sanatorio Italiano
City
Asuncion
Country
Paraguay
Facility Name
The Cardinal Stefan Wyszynski Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Silesian Center for Heart Diseases
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
10838539
Citation
Ratcliffe MB, Wallace AW, Teerlink JR, Hong J, Salahieh A, Sung SH, Keung EC, Lee RJ. Radio frequency heating of chronic ovine infarct leads to sustained infarct area and ventricular volume reduction. J Thorac Cardiovasc Surg. 2000 Jun;119(6):1194-204. doi: 10.1067/mtc.2000.105826.
Results Reference
background
PubMed Identifier
11901042
Citation
Victal OA, Teerlink JR, Gaxiola E, Wallace AW, Najar S, Camacho DH, Gutierrez A, Herrera G, Zuniga G, Mercado-Rios F, Ratcliffe MB. Left ventricular volume reduction by radiofrequency heating of chronic myocardial infarction in patients with congestive heart failure. Circulation. 2002 Mar 19;105(11):1317-22. doi: 10.1161/hc1102.105566.
Results Reference
background
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Feasibility Study of Radiofrequency Heating of Cardiac Infarction Scar to Treat Heart Failure
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