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COMPLETED
NCT04514757
NA

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

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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.

Official title: Transcutaneous (Tragus) Vagal Nerve Stimulation (tVNS) for Post-op Atrial Fibrillation (POAF)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

77

Start Date

2021-09-20

Completion Date

2024-04-25

Last Updated

2026-09-22

Healthy Volunteers

No

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.

Locations (2)

University of California, Los Angeles

Los Angeles, California, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States