CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 81 enrolled
Drug / intervention
Parasymdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03392649
NCT03392649N/ACompleted

Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery: The TraP-AF Study

University of Chicago·interventional·Posted Jan 8, 2018·Updated Aug 4, 2022

In Brief

A clinical study evaluating Parasym for Atrial Fibrillation. Completed, enrolled 81 participants across 1 site.

Detailed Summary

Patients undergoing cardiac surgery, specifically a coronary artery bypass graft and/or heart valve replacement surgery, are at a higher risk for post-procedure atrial fibrillation (AF). AF is a condition in which the upper chambers of the heart do not contract normally and results in an irregular heartbeat. Recent studies have shown that tragus stimulation decreases the likelihood of AF in animals and humans. It has also been shown to reduce inflammation which may be related to post-procedure AF. Tragus stimulation involves stimulating a part of the outer ear, called the tragus, by sending a microcurrent through a small alligator clip. It is believed that tragus stimulation can affect the nervous system, which may reduce heart rate and lead to prevention of AF. The purpose of this study is to determine whether tragus stimulation in subjects undergoing cardiac surgery will lead to shorter occurrences, or even prevention, of AF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsParasym Ltd.

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 8, 2018
Enrollment StartMar 9, 2018
Primary CompletionJul 30, 2021
Study CompletionJul 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.5 years ago

Interventions

Parasymdevice

Tragus stimulation was done using the Parasym device.