TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery

NCT03539354 | Unknown DMC

• 1 other identifier: TERMAF1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Coronary Artery Disease; Atrial Fibrillation

Keywords

Atrial fibrillation; Spinal cord stimulatoin; Coronary artery bypass grafting

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• 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

  30 days

• Hemodynamic parameter - Heart rate

  30 days

Study Arms (2)

CABG + b-blockers

ACTIVE COMPARATOR

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; Drug: B-blockers

CABG + b-blockers + temporary SCS

EXPERIMENTAL

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.

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

Interventions

Temporary spinal cord stimulation DEVICE

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.

CABG + b-blockers + temporary SCS

Coronary artery bypass grafting PROCEDURE

Standart coronary artery bypass grafting procedure.

CABG + b-blockers; CABG + b-blockers + temporary SCS

B-blockers DRUG

Standart b-blocker therapy will be administered in each group for AF prophylactics

CABG + b-blockers; CABG + b-blockers + temporary SCS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (2)

MedElect Clinic

Moscow, Russia

RECRUITING

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

RECRUITING

Related Publications (1)

• 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.

  PMID: 35177200 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation

Interventions

Coronary Artery Bypass; Endothelin B Receptor Antagonists

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Endothelin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Alexander B Romanov, PhD

CONTACT

+79137172652; abromanov@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 29, 2018
• Study Start: July 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: July 6, 2018

Record last verified: 2018-07

Locations

RU (2)