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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Biatrial radiofrequency ablation and CABG; Procedure: Left atrial radiofrequency ablation and 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 Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Recruiting
    • Meshalkin State Research Institute of Circulation Pathology
    • Contact: Sardor Rakhmonov; Phone Number: +79231278557; Email: sardor5507@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biatrial radiofrequency ablation and CABG; Biatrial radiofrequency ablation during CABG	Procedure: Biatrial radiofrequency ablation and CABG; Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.
Active Comparator: Left atrial radiofrequency ablation and CABG; Left atrial radiofrequency ablation during CABG	Procedure: Left atrial radiofrequency ablation and CABG; Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: September 19, 2014
• First Submitted That Met QC Criteria: September 22, 2014
• First Posted (Estimate): September 23, 2014

Study Record Updates

• Last Update Posted (Estimate): November 13, 2015
• Last Update Submitted That Met QC Criteria: November 12, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: ablation, CABG; Long-standing persistent Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Coronary Disease; Coronary Artery Disease; Atrial Fibrillation
• Other Study ID Numbers: LABARFA