Surgical Pulmonary Vein Isolation Efficiency Study (FIN-PVI)
Primary Purpose
Paroxysmal Atrial Fibrillation, Coronary Artery Disease
Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
CABG, AVR or CABG+AVR and PVI
CABG, AVR or CABG+AVR
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Pulmonary vein isolation, Paroxysmal atrial fibrillation, Quality of life
Eligibility Criteria
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
Sites / Locations
- Kuopio University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CABG, AVR or CABG+AVR and PVI
CABG, AVR or CABG+AVR
Arm 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
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
Outcomes
Primary Outcome Measures
Atrial fibrillation burden
Atrial fibrillation burden is defined as the amount of atrial fibrillation on one week Holter monitoring
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
Secondary Outcome Measures
Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation
Adverse events after surgery in both arms
Anti-arrhythmic treatment after surgery
Hospitalization due to atrial fibrillation after surgery
Cardioversion for the treatment of atrial fibrillation after surgery
Other cardiovascular related events: death, stroke, cardiac infarction, need for revascularization and bleeding
Full Information
NCT ID
NCT01791218
First Posted
February 12, 2013
Last Updated
September 1, 2020
Sponsor
Kuopio University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01791218
Brief Title
Surgical Pulmonary Vein Isolation Efficiency Study
Acronym
FIN-PVI
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Not enough patients for study arms
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Coronary Artery Disease
Keywords
Pulmonary vein isolation, Paroxysmal atrial fibrillation, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CABG, AVR or CABG+AVR and PVI
Arm Type
Experimental
Arm 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
Arm Title
CABG, AVR or CABG+AVR
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
CABG, AVR or CABG+AVR and PVI
Intervention Type
Procedure
Intervention Name(s)
CABG, AVR or CABG+AVR
Primary Outcome Measure Information:
Title
Atrial fibrillation burden
Description
Atrial fibrillation burden is defined as the amount of atrial fibrillation on one week Holter monitoring
Time Frame
Within one year after operative treatment
Title
Freedom of symptomatic and asymptomatic atrial fibrillation after surgery
Description
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
Time Frame
Within one year after operative treatment
Secondary Outcome Measure Information:
Title
Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation
Time Frame
Within one year after operative treatment
Title
Adverse events after surgery in both arms
Time Frame
Within one year after operative treatment
Title
Anti-arrhythmic treatment after surgery
Time Frame
Within one year after treatment
Title
Hospitalization due to atrial fibrillation after surgery
Time Frame
Within one year after operative treatment
Title
Cardioversion for the treatment of atrial fibrillation after surgery
Time Frame
Within one year after operative treatment
Title
Other cardiovascular related events: death, stroke, cardiac infarction, need for revascularization and bleeding
Time Frame
Within one year after operative treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Eastern Finland
ZIP/Postal Code
70211
Country
Finland
12. IPD Sharing Statement
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Surgical Pulmonary Vein Isolation Efficiency Study
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