Clinical trial NCT01791218: Surgical Pulmonary Vein Isolation Efficiency Study
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
Overall status: TERMINATED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Coronary Artery Disease
Keywords: Pulmonary vein isolation
Paroxysmal atrial fibrillation
Quality of life
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Atrial fibrillation burden
timeFrame: Within one year after operative treatment
measure: Freedom of symptomatic and asymptomatic atrial fibrillation after surgery
timeFrame: Within one year after operative treatment
Secondary outcomes:
measure: Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation
timeFrame: Within one year after operative treatment
measure: Adverse events after surgery in both arms
timeFrame: Within one year after operative treatment
measure: Anti-arrhythmic treatment after surgery
timeFrame: Within one year after treatment
measure: Hospitalization due to atrial fibrillation after surgery
timeFrame: Within one year after operative treatment
measure: Cardioversion for the treatment of atrial fibrillation after surgery
timeFrame: Within one year after operative treatment
measure: Other cardiovascular related events: death, stroke, cardiac infarction, need for revascularization and bleeding
timeFrame: Within one year after operative treatment
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Eastern Finland
Study officials:
References: