TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery (TerminationAF)

Meshalkin Research Institute of Pathology of Circulation

Status: Unknown

Conditions: Coronary Artery Disease; Atrial Fibrillation

Treatments: Device: Temporary spinal cord stimulation; Procedure: Coronary artery bypass grafting; Drug: B-blockers

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03539354

TERMAF1

Details and patient eligibility

About

To compare of atrial arrhythmia incidence in patients with coronary artery disease and atrial fibrillation history, undergoing either coronary artery bypass grafting plus temporary spinal cord stimulation or coronary artery bypass grafting alone

Full description

The study includes 60 patients. Patients are randomized into 2 groups: coronary artery bypass grafting plus b-blocker treatment (according to guidelines; group I) and coronary artery bypass grafting plus b-blocker treatment (according to guidelines) plus temporary spinal cord stimulation (group 2). Temporary spinal cord stimulation is performed for 3 days before surgery and 7 days after coronary artery bypass grafting. Continuous ECG during intensive care unit stay, daily ECG and 24-h Holter monitor recordings at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit until 30 days after coronary artery bypass grafting. Rhythm status and clinical outcome assessment at 12 month follow up

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

CABG + b-blockers

Active Comparator group

Description:

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.

Treatment:

Drug: B-blockers

Procedure: Coronary artery bypass grafting

CABG + b-blockers + temporary SCS

Experimental group

Description:

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.

Treatment:

Device: Temporary spinal cord stimulation

Drug: B-blockers

Procedure: Coronary artery bypass grafting