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Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.
Hypothesis of the study - patients with long-standing persistent atrial fibrillation and coronary artery disease after CABG in combination with biatrial RFA have a better outcomes for the freedom of AF compared with patients undergoing left atrial RFA during CABG.
This is a single blinded prospective randomized study involving 116 patients with long-standing persistent AF and coronary artery disease. 116 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome (freedom fro AF) measure by 12% in the biatrial group over left atrial group. Patients are divided into two groups, group I - biatrial + CABG (58 patients), and group II - left atrial + CABG (58 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 kind of surgical ablation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biatrial radiofrequency ablation and CABG | Active Comparator | Biatrial radiofrequency ablation during CABG |
|
| Left atrial radiofrequency ablation and CABG | Active Comparator | Left atrial radiofrequency ablation during CABG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biatrial radiofrequency ablation and CABG | Procedure | Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation | Freedom from AF. All cases of AF after surgical intervention. 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 |
|---|---|---|
| Cardiovascular events | All cases of stroke, cardiac infarction, thromboembolism, bleeding and death | Within three years after surgery |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sardor Rakhmonov | Contact | +79231278557 | sardor5507@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 |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Left atrial radiofrequency ablation and CABG | Procedure | Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB. |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |