NCT04514757Completed
Transcutaneous (Tragus) Vagal Nerve Stimulation for Post-op Afib
Transcutaneous (Tragus) Vagal Nerve Stimulation (tVNS) for Post-op Atrial Fibrillation (POAF)
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 77 (actual)
- First submitted
- 29 Jul 2020
- Start date
- 20 Sept 2021
- Primary completion date
- 25 Mar 2024
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Atrial fibrillation
- NCT number
- NCT04514757
What you commit to
- Study type: Interventional
- Participants enrolled: 77
- From 20 Sept 2021 to the primary completion date, 25 Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergent surgery
- Planned concomitant atrial Maze procedure
Other illness
- Complex congenital heart disease
- Left ventricular assist device or status post orthotopic heart or lung transplantation
- Complete heart block or trifascicular block without an implantable pacemaker
Lab values
- Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
Other
- Anticipated amiodarone use
- Patients with permanent or persistent atrial fibrillation
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
- Unable or unwilling to comply with protocol requirements.
- Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker.
- Recurrent vasovagal syncope
- Unilateral or bilateral vagotomy
- Chronic amiodarone use
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.