TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery

Coronary Artery Disease Clinical Trial

— TerminationAF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03539354
• Other study ID #: TERMAF1
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: May 2020

Study information

• Verified date: July 2018
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Alexander B Romanov, PhD
• Phone: +79137172652
• Email: abromanov[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Temporary spinal cord stimulation
Percutaneous trial (temporary) electrodes are placed through a 14-gauge needle.The skin is entered at the medial aspect of the pedicle with the Tuohy needle usually angled 30-45° toward the midline for optimal entry into the epidural space at the interlaminar edge 1 or 2 levels of cephalad (usually, Th5-Th6 level). The 14-gauge needle is then passed with the bevel facing up at a 30-45° oblique angle to reach the depth of the midline laminar target.The Tuohy needle is then carefully removed and the operative site is cleaned with chlorhexidine and alcohol. Temporary stimulation is carried out till coronary artery bypass grafting surgery for 3 days, then stimulation turns off during surgery. At the end of coronary artery bypass grafting the temporary stimulation turns on in the intensive care unit and continues for 7 days. After that, the temporary leads will be removed.

Procedure:
• Coronary artery bypass grafting
Standart coronary artery bypass grafting procedure.

Drug:
• B-blockers
Standart b-blocker therapy will be administered in each group for AF prophylactics

Locations

Country	Name	City	State
Russian Federation	MedElect Clinic	Moscow
Russian Federation	Novosibirsk Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events	MACE (Death, Stroke/TIA, Myocardial infarction), acute kidney injury, spinal cord injury	30 days
Primary	Occurrence of atrial tachyarrhythmias	Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting = 30 sec during 30 days after surgery	30 days
Primary	Occurrence of tachyarrhythmias	Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting = 30 sec 30 days after surgery	12 months
Secondary	Marker of myocardial injury - high-sensitive Troponin I		30 days
Secondary	Marker of myocardial injury - CK-MB		30 days
Secondary	Marker of kidney injury - Creatinine		30 days
Secondary	Hemodynamic parameter - Blood pressure	Invasive blood pressure, pulmonary artery pressure, central venous pressure, pulmonary artery wedge pressure	30 days
Secondary	Hemodynamic parameter - Heart rate		30 days
Secondary	Hemodynamic parameter - Cardiac index		30 days
Secondary	Hemodynamic parameter - Vascular resistance	Systemic vascular resistance, pulmonary artery resistance	30 days
Secondary	Acute pain assessment	The Wong-Baker Faces Pain Rating Scale	30 days
Secondary	Inotropic score		30 days
Secondary	Duration of mechanical ventilation		30 days
Secondary	Duration of intensive care unit stay		30 days
Secondary	Renal-replacement therapy		30 days