Arrhythmias, Cardiac, Cardiovascular Diseases, Myocardial Ischemia, Postoperative Atrial Fibrillation
Conditions
Keywords
Bipolar radiofrequency ablation, Atrial Fibrillation New Onset, CABG, Coronary artery disease, Postoperative atrial fibrillation
Brief summary
To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF.
Detailed description
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.
Interventions
PROCEDUREConventional CABG
Coronary artery bypass grafting
PROCEDURECABG+ PVI
CABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins
PROCEDURECABG+ PVI+amiodarone
CABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone)
PROCEDURECABG+amiodarone
Sponsors
Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
National Research Center of Surgery, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients must have signed an informed consent. * patients had indications for two or more coronary arteries to be bypassed * no history of AF
Exclusion criteria
* acute coronary syndrome * previous CABG. * a significant decrease in the contractile function of the heart (EF \<40%) * significant heart valve disease requiring surgical repair * long-standing persistent, persistent, or paroxysmal forms of atrial fibrillation * respiratory failure * left ventricular aneurysm requiring surgical correction * chronic renal failure (≤60 mL/min/1⋅73 m2) * chronic diseases that make a significant contribution to the prognosis of life (e.g. oncology) * participation in other clinical trials
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Incidence of implantation of the pacemaker | Through study completion, an average of 1 year |
| Length of stay in the intensive care unit | Through study completion, an average of 1 year |
| Time of CBP | Through study completion, an average of 1 year |
| Duration of the hospitalization | Through study completion, an average of 1 year |
| Volume of intraoperative bleeding | Through study completion, an average of 1 year |
| Time clamping of the aorta | Through study completion, an average of 1 year |
Countries
Russia
Contacts
Primary ContactAmiran Sh. Revishvili
Backup ContactVadim A. Popov
Outcome results
None listed