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NCT03392649 · ClinicalTrials.gov registry record · NA

Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery

A NA study, sponsored by University of Chicago.

Completed
Registry status
NA
Development phase
81
Enrollment target

NCT03392649: Completed NA study, sponsored by University of Chicago.

NCT03392649 is a NA study that has completed, run by University of Chicago. The registered enrollment target is 81 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03392649, a NA study, has completed, sponsored by University of Chicago.

COMPLETED
Registry status
NA
Development phase
81 participants
Enrollment target

Study 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.

Primary Outcome

Time to the first episode of atrial fibrillation (AF) that was greater than 30 seconds in patients who had AF. This was assessed on the review of patient chart and inpatient telemetry.

Interventions

  • DEVICE Parasym

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2018-03-09
Est. Completion 2021-07-31
Phase NA
University of Chicago

796 total trials

What the finished NCT03392649 record still lists

NCT03392649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which Parasym is the first listed.

NCT03392649 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03392649 about?

NCT03392649 is a clinical study titled "Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery". 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 h...

What is the current status of trial NCT03392649?

This trial is currently completed. It is a NA study. The enrollment target is 81 participants. The study started on 2018-03-09. Estimated completion is 2021-07-31.

What interventions are being tested in trial NCT03392649?

The interventions under investigation include: Parasym (DEVICE).

Who is sponsoring clinical trial NCT03392649?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03392649's enrollment target sits among peer trials

81 992nd of 2000 higher than 1,007 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03392649, the US trial registry maintained by the National Library of Medicine. NCT03392649 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.