Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2012-11-30
2020-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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 and PVI
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
CABG, AVR or CABG+AVR
Interventions
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CABG, AVR or CABG+AVR and PVI
CABG, AVR or CABG+AVR
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Kuopio University Hospital
OTHER
Responsible Party
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Locations
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Kuopio University Hospital
Kuopio, Eastern Finland, Finland
Countries
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Other Identifiers
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KUH5101071
Identifier Type: -
Identifier Source: org_study_id
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