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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
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
February 12, 2013
Last Updated
September 1, 2020
Sponsor
Kuopio University Hospital
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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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