Surgical Pulmonary Vein Isolation Efficiency Study

Not Applicable

Terminated

• Conditions: Paroxysmal Atrial Fibrillation; Coronary Artery Disease
• Interventions: Procedure: CABG, AVR or CABG+AVR and PVI; Procedure: CABG, AVR or CABG+AVR

• Registration Number: NCT01791218
• Lead Sponsor: Kuopio University Hospital

Brief Summary

A substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse short-and long term postoperative effects. Pulmonary vein isolation (PVI) seems to be effective treatment for paroxysmal atrial fibrillation. PVI can be done concomitantly with coronary artery bypass grafting, aortic valve replacement for aortic stenosis and combination of them. Procedure is well defined and safe.

There is a lack of convincing evidence of the effect on postoperative atrial fibrillation burden, quality of life and symptoms especially in correlation with atrial fibrillation paroxysms.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Status Verified: 2020-09
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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
• Duration of the atrial fibrillation episode must not exceed 1 week and it must reverse to sinus rhythm spontaneously or by cardioversion
• written and verbal consent

Exclusion Criteria

• 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
• Left atrial diameter less than 55mm assessed by transthoracic echocardiography
• Renal insufficiency requiring dialysis
• Heart valve disease requiring invasive treatment
• Heart anomaly requiring regular controls and/or invasive treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CABG, AVR or CABG+AVR and PVI	CABG, AVR or CABG+AVR and PVI	Coronary artery bypass (CABG), aortic valve replacement for aortic stenosis (AVR) or combination (CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation (PVI) in CBP prior to occlusion and CABG
CABG, AVR or CABG+AVR	CABG, AVR or CABG+AVR	Coronary artery bypass (CABG), aortic valve replacement for aortic stenosis(AVR) or combination(CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. No operative procedures for the treatment of atrial fibrillation

Primary Outcome Measures

Name	Time	Method
Freedom of symptomatic and asymptomatic atrial fibrillation after surgery	Within one year after operative treatment	Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds.; Freedom of atrial fibrillation is defined as duration of atrial fibrillation less than 0,5% of the one week Holter monitoring
Atrial fibrillation burden	Within one year after operative treatment	Atrial fibrillation burden is defined as the amount of atrial fibrillation on one week Holter monitoring

Secondary Outcome Measures

Name	Time	Method
Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation	Within one year after operative treatment
Anti-arrhythmic treatment after surgery	Within one year after treatment
Adverse events after surgery in both arms	Within one year after operative treatment
Hospitalization due to atrial fibrillation after surgery	Within one year after operative treatment
Other cardiovascular related events: death, stroke, cardiac infarction, need for revascularization and bleeding	Within one year after operative treatment
Cardioversion for the treatment of atrial fibrillation after surgery	Within one year after operative treatment

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Eastern Finland, Finland