Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery (TraP-AF)

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

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Parasym

Detailed Description

This was a single-blind study where patients were randomized tragus stimulation versus sham procedure and remained blinded to their treatment allocation. Both treatment options utilized similar equipment, namely the use of alligator clips which will be placed on the tragus and earlobe of the right ear for patients.

Prior to cardiac surgery, the discomfort threshold of both left and right tragus stimulation was determined for all participating patients. Intermittent electrode signals, or microcurrents, were delivered at 20 Hz with100 µsec pulse width with variable microampere (mA) output. The discomfort threshold was defined as the stimulation intensity in mA at which point patients experience discomfort. The stimulation intensity used in the study was set below the sensation and discomfort threshold. The clip was placed on the patient's ear at the end of surgery. Stimulation then continued, one ear alternating with the other, every 4 hours for a total of 48 hours. If the patient showed any sign of discomfort from stimulation, the intensity of stimulation was reduced to a level at which signs of discomfort disappears.

Follow-up was performed with a 14-day event monitor at the time of discharge, as clinically indicated. Echocardiography were assessed prior to study initiation and when clinically available in follow-up.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients ≥18 years of age, <90 years of age
2. Estimated life expectancy of at least 1 year at the time of enrollment
3. History of sinus rhythm or paroxysmal atrial fibrillation

Exclusion Criteria:

1. Patients ≥90 years of age, <18 years
2. Patients with known prior history of persistent or permanent AF
3. Atrial Fibrillation occurrence within the last 24 hours of procedure
4. Urgent or Emergency cases
5. Pregnant patients
6. Patients undergoing the following cardiac procedures: heart transplant, pulmonary thromboendarterectomy, isolated aortic arch procedures, congenital hear disease, ventricular assist device insertion, extracorporeal membrane oxygenation insertion, and surgical AF ablation
7. Antiarrhythmics prior to surgery (Class I and Class III)
8. High degree atrioventricular block requiring temporary pacing
9. Prior maze procedure for the treatment of AF

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Parasym; Tragus stimulation was done using the Parasym device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the First Episode of Atrial Fibrillation (AF) >30 Seconds	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.	From end of surgery to end of hospitalization, up to 1 month.
Number of Participants Hospitalized for >5 Days	Number of participants with an overall length of hospitalization greater than five days.	From end of surgery to end of hospitalization, up to 1 month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Atrial Fibrillation (AF) Burden	The total number of hours of atrial fibrillation (AF) burden as an inpatient.	From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Rate Control Medications Used for AF	Number of participants that the management of their postoperative atrial fibrillation (AF) utilized the use of rate-controlling medications such as beta-blockers, calcium-channel blockers, or the use of digoxin.	From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Antiarrhythmic Used to Treat AF	Number of participants that antiarrhythmic was use to treat atrial fibrillation (i.e., use of amiodarone)	From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Inotropes Used for Blood Pressure Support During AF	The number of participants who management of their postoperative atrial fibrillation (AF) required the use of inotropic vasoactive or pressor medications for blood pressure (BP) support	From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Stroke or Transient Ischemic Attack (TIA)	The number of participants who suffered from a cerebral vascular accident (CVA) or transient ischemic attacks (TIA) for any cause during hospitalization was recorded.	From end of surgery to end of hospitalization, up to 1 month.
All-cause Mortality	Number of participants who suffered from mortality due to any cause during the inpatient period	From end of surgery to end of hospitalization, up to 1 month.

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Parasym Ltd.
• Investigators: Principal Investigator: Gaurav A. Upadhyay, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative Atrial Fibrillation; Tragus Stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: IRB17-1365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes