Surgical Pulmonary Vein Isolation Efficiency Study (FIN-PVI)

Kuopio University Hospital

Status: Terminated

Conditions: Paroxysmal Atrial Fibrillation; Coronary Artery Disease

Treatments: Procedure: CABG, AVR or CABG+AVR and PVI; Procedure: CABG, AVR or CABG+AVR

Study type: Interventional

Funder types: Other

Identifiers

NCT01791218

KUH5101071

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

CABG, AVR or CABG+AVR and PVI

Experimental group

Description:

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

Treatment:

Procedure: CABG, AVR or CABG+AVR and PVI

CABG, AVR or CABG+AVR

Active Comparator group

Description:

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

Treatment:

Procedure: CABG, AVR or CABG+AVR