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
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
20-001636
Category
Heart/Cardiovascular Diseases
Principal Investigator
Contact
Location
- UCLA Westwood