TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery

Meshalkin Research Institute of Pathology of Circulation60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Coronary Artery Disease Atrial Fibrillation

Interventions

Temporary spinal cord stimulationDEVICE

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.

Coronary artery bypass graftingPROCEDURE

Standart coronary artery bypass grafting procedure.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

MedElect Clinic

Moscow, Russia

RECRUITING

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, Russia

RECRUITING

Outcomes

Primary Outcomes

Occurrence of adverse events

MACE (Death, Stroke/TIA, Myocardial infarction), acute kidney injury, spinal cord injury

Time frame: 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

Time frame: 30 days

Occurrence of tachyarrhythmias

Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec 30 days after surgery

Time frame: 12 months

Secondary Outcomes

Marker of myocardial injury - high-sensitive Troponin I

Time frame: 30 days

Marker of myocardial injury - CK-MB

Time frame: 30 days

Marker of kidney injury - Creatinine

Time frame: 30 days

Hemodynamic parameter - Blood pressure

Invasive blood pressure, pulmonary artery pressure, central venous pressure, pulmonary artery wedge pressure

Time frame: 30 days

Hemodynamic parameter - Heart rate

Time frame: 30 days

Hemodynamic parameter - Cardiac index

Time frame: 30 days

Hemodynamic parameter - Vascular resistance

Central Contacts

Alexander B Romanov, PhD

CONTACT

+79137172652 abromanov@mail.ru

Data from ClinicalTrials.gov

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