The Assessment of Progression of Paroxysmal AF After CABG

Phase 3

• Conditions: Paroxysmal Atrial Fibrillation, Coronary Artery Disease

• Registration Number: NCT02246803
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

The aim of this study is a comparative evaluation of progression of paroxysmal atrial fibrillation in patients with coronary artery disease after isolated CABG and CABG combined with pulmonary vein isolation.

Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery disease after CABG in combination with isolation of the pulmonary veins have a better outcomes for the progression of AF compared with patients undergoing isolated CABG.

Detailed Description

This is a single blinded prospective randomized study involving 72 patients with paroxysmal AF and coronary artery disease. 72 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure by 10% in the CABG + pulmonary veins isolation group over isolated CABG group. Patients are divided into two groups, group I - isolated CABG (36 patients), and group II - CABG and pulmonary veins isolation (36 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 pulmonary vein isolation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-22
• Study First Posted: 2014-09-23
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23
• Primary Completion: 2015-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• American College of Cardiology (ACC)/ American Heart Association (AHA) -Indications for CABG
• At least 2 ECG-verified (12-channel ECG, Holter telemetry) symptomatic paroxysmal atrial fibrillation episodes 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression of atrial fibrillation	up to 36 months	Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF.; 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
Hospitalization due to atrial fibrillation after surgery	Within three years after surgery	All cases of hospitalization due to atrial fibrillation after surgery

Trial Locations

Locations (1)

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