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

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• Patients ≥18 years of age, \<90 years of age

• Estimated life expectancy of at least 1 year at the time of enrollment

• History of sinus rhythm or paroxysmal atrial fibrillation

Locations
United States
Illinois
The University of Chicago
Chicago
Time Frame
Start Date: 2018-03-09
Completion Date: 2021-07-31
Participants
Target number of participants: 81
Treatments
No_intervention: Sham Group
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip was switched to the other ear every 4 hours for a total of 48 hours.
Experimental: Stimulation Group
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Related Therapeutic Areas
Sponsors
Leads: University of Chicago
Collaborators: Parasym Ltd.

This content was sourced from clinicaltrials.gov

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