Surgical Ablation of Long-standing Persistent AF During CABG

Coronary Artery Disease Clinical Trial

— LABARFA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02246790
• Other study ID #: LABARFA
• Status: Recruiting
• Phase: Phase 3
• First received: September 19, 2014
• Last updated: November 12, 2015
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Sardor Rakhmonov
• Phone: +79231278557
• Email: sardor5507[@]mail.ru
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Biatrial radiofrequency ablation and CABG
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.
• Left atrial radiofrequency ablation and CABG
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.

Locations

Country	Name	City	State
Russian Federation	Meshalkin State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cardiovascular events	All cases of stroke, cardiac infarction, thromboembolism, bleeding and death	Within three years after surgery	No