MedTrace Logo

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

NCT04514757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-02-24

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

active tVNS

20 Hz, 250ms at a current just below discomfort threshold for one hour twice a day, starting on post-day 0. Stimulation will continue until 5 days post-operatively or discharge.

DEVICE

sham tVNS

Current set a 0 mA, starting on post-op day 0. Stimulation will continue until 5 days post-operatively or discharge.

Sponsors & Collaborators

Principal Investigators

  • Jonathan Ho, MD · University of California, Los Angeles

  • Marmar Vaseghi, MD · University of California, Los Angeles

  • Stavros Stavrakis, MD, PhD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2024-03-25
Completion
2024-04-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04514757 on ClinicalTrials.gov