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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CABG+pulmonary vein isolation | Active Comparator | CABG+pulmonary vein isolation procedure |
|
| Isolated CABG | Active Comparator | Isolated CABG procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CABG+Pulmonary vein isolation procedure | Procedure | Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of atrial fibrillation | 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. | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization due to atrial fibrillation after surgery | All cases of hospitalization due to atrial fibrillation after surgery | Within three years after surgery |
| Cardiovascular events | All cases of stroke, cardiac infarction, thromboembolism, bleeding and death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia Kareva | Contact | +79069952839 | julia11108@mail.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meshalkin State Research Institute of Circulation Pathology | Recruiting | Novosibirsk | 630055 | Russia |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Isolated CABG | Procedure | Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. |
|
| Within three years after surgery |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |