The Assessment of Progression of Paroxysmal AF After CABG

The Assessment of Progression of Paroxysmal Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting Through Continuous Subcutaneous Monitoring

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.

Study Overview

• Status: Unknown
• Conditions: Paroxysmal Atrial Fibrillation, Coronary Artery Disease
• Intervention / Treatment: Procedure: CABG+Pulmonary vein isolation procedure; Procedure: 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 Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Recruiting
    • Meshalkin State Research Institute of Circulation Pathology
    • Contact: Julia Kareva, PhD; Phone Number: +79069952839; Email: julia11108@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 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) 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: CABG+pulmonary vein isolation; CABG+pulmonary vein isolation procedure	Procedure: CABG+Pulmonary vein isolation procedure; Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG
ACTIVE_COMPARATOR: Isolated CABG; Isolated CABG procedure	Procedure: Isolated CABG; Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of atrial fibrillation	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.	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
Hospitalization due to atrial fibrillation after surgery	All cases of hospitalization due to atrial fibrillation after surgery	Within three years after surgery

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Study record dates

Study Major Dates

• Study Start: January 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): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: paroxysmal atrial fibrillation, CABG, pulmonary vein isolation
• 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: AF-Progress