Clinical trial NCT03539354: TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery
Official title: TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery (TerminationAF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Atrial Fibrillation
Keywords: Atrial fibrillation
Spinal cord stimulatoin
Coronary artery bypass grafting
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2018-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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

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.

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: 30 days
measure: Occurrence of atrial tachyarrhythmias
timeFrame: 30 days
measure: Occurrence of tachyarrhythmias
timeFrame: 12 months
Secondary outcomes:
measure: Marker of myocardial injury - high-sensitive Troponin I
timeFrame: 30 days
measure: Marker of myocardial injury - CK-MB
timeFrame: 30 days
measure: Marker of kidney injury - Creatinine
timeFrame: 30 days
measure: Hemodynamic parameter - Blood pressure
timeFrame: 30 days
measure: Hemodynamic parameter - Heart rate
timeFrame: 30 days
measure: Hemodynamic parameter - Cardiac index
timeFrame: 30 days
measure: Hemodynamic parameter - Vascular resistance
timeFrame: 30 days
measure: Acute pain assessment
timeFrame: 30 days
measure: Inotropic score
timeFrame: 30 days
measure: Duration of mechanical ventilation
timeFrame: 30 days
measure: Duration of intensive care unit stay
timeFrame: 30 days
measure: Renal-replacement therapy
timeFrame: 30 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: MedElect Clinic
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Circulation Pathology
Study officials:
References:
citation: Romanov A, Lomivorotov V, Chernyavskiy A, Murtazin V, Kliver E, Ponomarev D, Mikheenko I, Yakovlev A, Yakovleva M, Steinberg JS. Temporary Spinal Cord Stimulation to Prevent Postcardiac Surgery Atrial Fibrillation: 30-Day Safety and Efficacy Outcomes. J Am Coll Cardiol. 2022 Feb 22;79(7):754-756. doi: 10.1016/j.jacc.2021.08.078. No abstract available.