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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
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.
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.
Sanatorio Italiano
Asunción, Paraguay
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, Poland
Silesian Center for Heart Diseases
Zabrze, Poland
Change in Left Ventricular End Diastolic and Systolic Volume Indexes as measured by Cardiac MRI/CT
Time frame: 6 Months
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
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
Change in New York Heart Association Functional Classification and Canadian Cardiovascular Society Angina Grading Scale
Time frame: 1, 3, 6, and 12 months
Change in Cardiopulmonary Exercise Stress Test (Peak VO2 and VE/VCO2 slope)
Time frame: 6 and 12 months
Change in 6-Minute Walk distance
Time frame: 1, 3, 6, and 12 months
Change in Quality of Life Questionnaire score (Minnesota Living With Heart Failure and EuroQol EQ-5D)
Time frame: 1, 3, 6, and 12 months
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
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Enrollment
3