Surgical Ablation of Long-standing Persistent AF During CABG

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Surgical Ablation of Long-standing Persistent Atrial Fibrillation During CABG Through Continuous Subcutaneous Monitoring

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Biatrial radiofrequency ablation and CABG
* Procedure: Left atrial radiofrequency ablation and 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) long-term persistent AF 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: 75 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: Biatrial radiofrequency ablation and CABG<br>Biatrial radiofrequency ablation during CABG | Procedure: Biatrial radiofrequency ablation and CABG<br>* Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.<br>|
| Active Comparator: Left atrial radiofrequency ablation and CABG<br>Left atrial radiofrequency ablation during CABG | Procedure: Left atrial radiofrequency ablation and CABG<br>* Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial fibrillation | Freedom from AF. All cases of AF after surgical intervention. 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 |
| --- | --- | --- |
| 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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ablation, CABG, Long-standing persistent Atrial Fibrillation