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| Name | Class |
|---|---|
| Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia. | UNKNOWN |
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To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF.
Prospective, multicenter, randomized trial, intended to compare three prophylactic strategies of atrial fibrillation in patients with coronary artery disease and without history of atrial fibrillation.
The study includes 4 groups of patients:
Group I (conventional CABG)
Group II (CABG + pulmonary veins isolation). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins isolation.
Group III (CABG+ pulmonary veins isolation + amiodarone). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins ablation with administration of amiodarone in postoperative periode.
Group IV (CABG+ amiodarone). Conventional CABG with administration of amiodarone in postoperative periode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional CABG | Active Comparator | Coronary artery bypass grafting (CABG) treatment (CABG group,n=70) |
|
| CABG+ PVI | Active Comparator | CABG + prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation (CABG +PVI group, n=70) |
|
| CABG+ PVI+amiodarone | Active Comparator | CABG+ prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation + amiodarone (CABG +PVI+ class III antiarrhythmic drug- amiodarone, group, n=70) |
|
| CABG+amiodarone | Active Comparator | CABG+class III antiarrhythmic drug- amiodarone, group, n=70 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional CABG | Procedure | Coronary artery bypass grafting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of atrial fibrillation after CABG | Through study completion, an average of 1 year | |
| Major cardiovascular and cerebral events (MACCE), including death, nonfatal myocardial infarction, repeated revascularization using PCI or CABG, transitory ischemic attack (TIA) or stroke. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sinus rhythm at the time of discharge of the patient from the hospital | Through study completion, an average of 1 year | |
| Duration of mechanical ventilation | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amiran Sh. Revishvili | Contact | +7 (499) 236-72-90 | ||
| Vadim A. Popov | Contact | +7 9166706609 | drpopov@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Amiran Sh. Revishvili | A.V. Vishnevsky National Medical Research Center of Surgery. Moscow. Russian Federation. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia. | Recruiting | Kaliningrad | 236035 | Russia |
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| CABG+ PVI |
| Procedure |
CABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins |
|
| CABG+ PVI+amiodarone | Procedure | CABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone) |
|
| CABG+amiodarone | Procedure |
|
| Incidence of implantation of the pacemaker | Through study completion, an average of 1 year |
| Volume of intraoperative bleeding | Through study completion, an average of 1 year |
| Time of CBP | Through study completion, an average of 1 year |
| Time clamping of the aorta | Through study completion, an average of 1 year |
| Length of stay in the intensive care unit | Through study completion, an average of 1 year |
| Duration of the hospitalization | Through study completion, an average of 1 year |
| A.V. Vishnevsky National Medical Research Center of Surgery. | Recruiting | Moscow | 117997 | Russia |
|
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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