Paroxysmal Atrial Fibrillation, Coronary Artery Disease
Conditions
Keywords
paroxysmal atrial fibrillation, CABG, pulmonary vein isolation
Brief summary
The aim of this study is a comparative evaluation of progression of paroxysmal atrial fibrillation in patients with coronary artery disease after isolated CABG and CABG combined with pulmonary vein isolation. Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery disease after CABG in combination with isolation of the pulmonary veins have a better outcomes for the progression of AF compared with patients undergoing isolated CABG.
Detailed description
This is a single blinded prospective randomized study involving 72 patients with paroxysmal AF and coronary artery disease. 72 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure by 10% in the CABG + pulmonary veins isolation group over isolated CABG group. Patients are divided into two groups, group I - isolated CABG (36 patients), and group II - CABG and pulmonary veins isolation (36 patients). Randomization is conducted by using accidental sampling before operation. The blinding process is applied to a patient, who is informed about received coronary artery bypass grafting, but don't know about pulmonary vein isolation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.
Interventions
PROCEDURECABG+Pulmonary vein isolation procedure
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG
PROCEDUREIsolated CABG
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
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 * The patient's consent to participate in the study
Exclusion criteria
* Intolerance of antiarrhythmic drugs * Heart valve disease requiring invasive treatment * Left atria more than 6.5 cm * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression of atrial fibrillation | up to 36 months | Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF. Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF\>0.5% were classified as non-responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization due to atrial fibrillation after surgery | Within three years after surgery | All cases of hospitalization due to atrial fibrillation after surgery |
| Cardiovascular events | Within three years after surgery | All cases of stroke, cardiac infarction, thromboembolism, bleeding and death |
Countries
Russia
Contacts
Primary ContactJulia Kareva
Outcome results
None listed