Overview

TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery

Status:
Unknown status
Trial end date:
2020-05-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
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.