Coronary Artery Disease Clinical Trial
Official title:
Surgical Ablation of Long-standing Persistent Atrial Fibrillation During CABG Through Continuous Subcutaneous Monitoring
Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and
biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.
Hypothesis of the study - patients with long-standing persistent atrial fibrillation and
coronary artery disease after CABG in combination with biatrial RFA have a better outcomes
for the freedom of AF compared with patients undergoing left atrial RFA during CABG.
This is a single blinded prospective randomized study involving 116 patients with long-standing persistent AF and coronary artery disease. 116 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome (freedom fro AF) measure by 12% in the biatrial group over left atrial group. Patients are divided into two groups, group I - biatrial + CABG (58 patients), and group II - left atrial + CABG (58 patients). Randomization is conducted by using accidental sampling before operation. The blinding process is applied to a patient, who is informed about received coronary artery bypass grafting, but don't know about kind of surgical ablation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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