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TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery

NCT03539354 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-07-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-05-31
Completion
2020-05-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03539354 on ClinicalTrials.gov