Open Actively Recruiting

Transcutaneous (Tragus) Vagal Nerve Stimulation for Post-op Afib

About

Brief 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.

Primary Purpose
Prevention
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
80 Years

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).
  • Left ventricular assist device or status post orthotopic heart or lung transplantation
  • Unable or unwilling to comply with protocol requirements.
  • Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
  • Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker.
  • Complete heart block or trifascicular block without an implantable pacemaker
  • Recurrent vasovagal syncope
  • Unilateral or bilateral vagotomy
  • Chronic amiodarone use

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
20-001636
Category
Anesthesiology & Perioperative Medicine
Contact
Jennifer Scovotti
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04514757
For detailed technical eligibility, visit ClinicalTrials.gov.