TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery (TerminationAF)
Coronary Artery Disease, Atrial Fibrillation
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Atrial fibrillation, Spinal cord stimulatoin, Coronary artery bypass grafting
Eligibility Criteria
Inclusion Criteria:
- age 18-80 years;
- indications for coronary artery bypass grafting according to guidelines;
- pre-operative history of paroxysmal atrial fibrillation;
- absent of contraindications for spinal cord stimulation;
- signed inform consent.
Exclusion Criteria:
- previous heart surgery or atrial fibrillation ablation procedure;
- emergency coronary artery bypass grafting;
- left ventricle ejection fraction <35%;
- unstable angina or heart failure;
- persistent atrial fibrillation or atrial fibrillation at the time of screening;
- planned Maze procedure or pulmonary vein isolation;
- use of class I or III antiarrhythmic drugs within 5 elimination half-lives of the drug;
- need for concomitant valve surgery;
- Inability to control the device for spinal cord stimulation;
- coagulopathy, immunosuppression, or other condition associated with an unacceptable surgical risk for spinal cord stimulation;
- Need for therapeutic diathermy in the area of leads placement;
- Need for pacemaker/ICD/CRT-D implantation;
- unwillingness to participate.
Sites / Locations
- MedElect ClinicRecruiting
- Novosibirsk Research Institute of Circulation PathologyRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
CABG + b-blockers
CABG + b-blockers + temporary SCS
Standart coronary artery bypass grafting is performed with b-blockers treatment. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting.
Before coronary artery bypass grafting in the experimental group, 3 days of temporary spinal cord stimulation is performed than device turned off and coronary artery bypass grafting procedure is made. The device for spinal cord is turned on in intensive care unit for 7 days. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting.