Paroxysmal Atrial Fibrillation, Coronary Artery Disease Clinical Trial
Official title:
The Assessment of Progression of Paroxysmal Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting Through Continuous Subcutaneous Monitoring
The aim of this study is a comparative evaluation of progression of paroxysmal atrial
fibrillation in patients with coronary artery disease after isolated CABG and CABG combined
with pulmonary vein isolation.
Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery
disease after CABG in combination with isolation of the pulmonary veins have a better
outcomes for the progression of AF compared with patients undergoing isolated CABG.
This is a single blinded prospective randomized study involving 72 patients with paroxysmal AF and coronary artery disease. 72 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure by 10% in the CABG + pulmonary veins isolation group over isolated CABG group. Patients are divided into two groups, group I - isolated CABG (36 patients), and group II - CABG and pulmonary veins isolation (36 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 pulmonary vein isolation. 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