Transcutaneous (Tragus) Vagal Nerve Stimulation for Post-op Afib
United States77 participantsStarted 2021-09-20
Plain-language summary
Patients undergoing cardiac surgery are at high risk of developing atrial fibrillation (AF), with estimated rates of 30-50% and occurs at approximately 2-4 days after surgery. The autonomic nervous system is known to play a key role in AF. Animal studies have indicated that duration and inducibility of AF can be decreased with intermittent vagus nerve stimulation (VNS). In humans, literature suggests that transcutaneous (tragus) VNS (tVNS) can serve as a potentially non-invasive therapy for treatment of post-operative AF (POAF) by reducing inflammation and increasing atrial refractory period. The purpose of this study is to determine the value of tVNS in reducing the burden of POAF and days of hospitalization after cardiac surgery.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients scheduled to undergo coronary artery bypass surgery, major vascular/aneurysm repair requiring bypass, valvular replacement or repair, or both, for clinically indicated reasons.
✓. Age ≥ 18 years.
✓. Sinus rhythm at baseline.
✓. Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study
Exclusion criteria
✕. Emergent surgery
✕. Anticipated amiodarone use
✕. Patients with permanent or persistent atrial fibrillation
✕. Planned concomitant atrial Maze procedure
✕. Complex congenital heart disease
✕. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).