Surgical Ablation of Long-standing Persistent AF During CABG

Phase 3

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Biatrial radiofrequency ablation and CABG; Procedure: Left atrial radiofrequency ablation and CABG

• Registration Number: NCT02246790
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-22
• Study First Posted: 2014-09-23
• Study Start: 2014-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-12
• Last Update Posted: 2015-11-13
• Primary Completion: 2015-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biatrial radiofrequency ablation and CABG	Biatrial radiofrequency ablation and CABG	Biatrial radiofrequency ablation during CABG
Left atrial radiofrequency ablation and CABG	Left atrial radiofrequency ablation and CABG	Left atrial radiofrequency ablation during CABG

Primary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation	up to 36 months	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.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular events	Within three years after surgery	All cases of stroke, cardiac infarction, thromboembolism, bleeding and death

Trial Locations

Locations (1)

Meshalkin State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation