Feasibility Study of Radiofrequency Heating of Cardiac Infarction Scar to Treat Heart Failure
NCT00881777 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2011-07-14
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.
Conditions
Interventions
- PROCEDURE
-
Radiofrequency heating of the myocardial infarct scar
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.
- PROCEDURE
-
Coronary Artery Bypass Grafting (CABG) surgery
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.
Sponsors & Collaborators
-
CoRepair, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2011-03-31
- Completion
- 2011-03-31
Countries
- Paraguay
- Poland
Study Locations
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