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

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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Atrial Fibrillation
• Intervention / Treatment: Procedure: Coronary artery bypass grafting; Drug: B-blockers; Device: Temporary spinal cord stimulation

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • MedElect Clinic
    • Contact: Alexander Yakovlev
  • Novosibirsk, Russian Federation, 630055
    • Recruiting
    • Novosibirsk research institute of circulation pathology
    • Contact: Andrey Ponomrenko, MD; Phone Number: +79628316017; Email: andreyvictorovich92@mail.ru
    • Sub-Investigator: Igor Mikheenko, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: CABG + b-blockers; 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.	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
EXPERIMENTAL: CABG + b-blockers + temporary SCS; 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.	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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events	MACE (Death, Stroke/TIA, Myocardial infarction), acute kidney injury, spinal cord injury	30 days
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation		30 days
Marker of myocardial injury - high-sensitive Troponin I		30 days
Marker of myocardial injury - CK-MB		30 days
Marker of kidney injury - Creatinine		30 days
Hemodynamic parameter - Blood pressure	Invasive blood pressure, pulmonary artery pressure, central venous pressure, pulmonary artery wedge pressure	30 days
Hemodynamic parameter - Heart rate		30 days
Hemodynamic parameter - Cardiac index		30 days
Hemodynamic parameter - Vascular resistance	Systemic vascular resistance, pulmonary artery resistance	30 days
Acute pain assessment	The Wong-Baker Faces Pain Rating Scale	30 days
Inotropic score		30 days
Duration of intensive care unit stay		30 days
Renal-replacement therapy		30 days

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (ACTUAL): May 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Coronary artery bypass grafting; Spinal cord stimulatoin
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Coronary Disease; Coronary Artery Disease; Atrial Fibrillation
• Other Study ID Numbers: TERMAF1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No