Surgical Ablation of Long-standing Persistent AF During CABG (LABARFA)

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 3

Conditions: Coronary Artery Disease

Treatments: Procedure: Left atrial radiofrequency ablation and CABG; Procedure: Biatrial radiofrequency ablation and CABG

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02246790

LABARFA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Biatrial radiofrequency ablation and CABG

Active Comparator group

Description:

Biatrial radiofrequency ablation during CABG

Treatment:

Procedure: Biatrial radiofrequency ablation and CABG

Left atrial radiofrequency ablation and CABG

Active Comparator group

Description:

Left atrial radiofrequency ablation during CABG

Treatment:

Procedure: Left atrial radiofrequency ablation and CABG