Surgical Pulmonary Vein Isolation Efficiency Study (FIN-PVI)

Concomitant Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation Patients Undergoing Elective Coronary Artery Bypass Grafting and Aortic Valve Replacement for Aortic Stenosis: a Prospective Study

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: CABG, AVR or CABG+AVR and PVI; Procedure: CABG, AVR or CABG+AVR

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Eastern Finland
    • Kuopio, Eastern Finland, Finland, 70211
      • Kuopio University Hospital

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
• 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 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
EXPERIMENTAL: 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	Procedure: CABG, AVR or CABG+AVR and PVI
ACTIVE_COMPARATOR: 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	Procedure: CABG, AVR or CABG+AVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation burden	Atrial fibrillation burden is defined as the amount of atrial fibrillation on one week Holter monitoring	Within one year after operative treatment
Freedom of symptomatic and asymptomatic atrial fibrillation after surgery	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	Within one year after operative treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation	Within one year after operative treatment
Adverse events after surgery in both arms	Within one year after operative treatment
Anti-arrhythmic treatment after surgery	Within one year after treatment
Hospitalization due to atrial fibrillation after surgery	Within one year after operative treatment
Cardioversion for the treatment of 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

Collaborators and Investigators

• Sponsor: Kuopio University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (ESTIMATE): February 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Paroxysmal atrial fibrillation; 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: KUH5101071