The Assessment of Progression of Paroxysmal AF After CABG

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Assessment of Progression of Paroxysmal Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting Through Continuous Subcutaneous Monitoring

Conditions
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Paroxysmal Atrial Fibrillation, Coronary Artery Disease

Intervention / Treatment
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* Procedure: CABG+Pulmonary vein isolation procedure
* Procedure: Isolated CABG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American College of Cardiology (ACC)/ American Heart Association (AHA) -Indications for CABG At least 2 ECG-verified (12-channel ECG, Holter telemetry) symptomatic paroxysmal atrial fibrillation episodes within last 12 months The patient's consent to participate in the study Exclusion Criteria: Intolerance of antiarrhythmic drugs Heart valve disease requiring invasive treatment Left atria more than 6.5 cm Prior cardiac surgery Active pacemaker treatment Active anti-arrhythmic treatment (AAD) class I and III Contraindication to oral anticoagulant/heparin treatment Ejection fraction less than 30 % (EF < 30 %) assessed by transthoracic echocardiography

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CABG+pulmonary vein isolation<br>CABG+pulmonary vein isolation procedure | Procedure: CABG+Pulmonary vein isolation procedure<br>* Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG<br>|
| Active Comparator: Isolated CABG<br>Isolated CABG procedure | Procedure: Isolated CABG<br>* Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of atrial fibrillation | Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF. Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF>0.5% were classified as non-responders. | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization due to atrial fibrillation after surgery | All cases of hospitalization due to atrial fibrillation after surgery | Within three years after surgery | 
| Cardiovascular events | All cases of stroke, cardiac infarction, thromboembolism, bleeding and death | Within three years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paroxysmal atrial fibrillation, CABG, pulmonary vein isolation