Coronary Artery Disease, Paroxysmal Atrial Fibrillation
Conditions
Keywords
Pulmonary vein isolation, Paroxysmal atrial fibrillation, Quality of life
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.
Interventions
PROCEDURECABG, AVR or CABG+AVR and PVI
PROCEDURECABG, AVR or CABG+AVR
Sponsors
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation burden | Within one year after operative treatment | 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 | Within one year after operative treatment | 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
| Measure | Time frame |
|---|---|
| Anti-arrhythmic treatment after surgery | Within one year after treatment |
| Hospitalization due to atrial fibrillation after surgery | Within one year after operative treatment |
| Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation | 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 |
| Cardioversion for the treatment of atrial fibrillation after surgery | Within one year after operative treatment |
| Adverse events after surgery in both arms | Within one year after operative treatment |
Countries
Finland
Outcome results
None listed