The Assessment of Progression of Paroxysmal AF After CABG

Paroxysmal Atrial Fibrillation, Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02246803
• Other study ID #: AF-Progress
• Status: Recruiting
• Phase: Phase 3
• First received: September 19, 2014
• Last updated: September 21, 2015
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Julia Kareva
• Phone: +79069952839
• Email: julia11108[@]mail.ru
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 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) 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

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
• Paroxysmal Atrial Fibrillation, Coronary Artery Disease

Intervention

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
• Isolated CABG
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion.

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	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	No
Secondary	Hospitalization due to atrial fibrillation after surgery	All cases of hospitalization due to atrial fibrillation after surgery	Within three years after surgery	No
Secondary	Cardiovascular events	All cases of stroke, cardiac infarction, thromboembolism, bleeding and death	Within three years after surgery	No