TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-05-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Coronary Artery Disease Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Coronary artery bypass grafting

Intervention Type PROCEDURE

Standart coronary artery bypass grafting procedure.

B-blockers

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Temporary spinal cord stimulation

Intervention Type 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.

Coronary artery bypass grafting

Intervention Type PROCEDURE

Standart coronary artery bypass grafting procedure.

B-blockers

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DEVICE

Coronary artery bypass grafting

Standart coronary artery bypass grafting procedure.

Intervention Type PROCEDURE

B-blockers

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No