Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery

Atrial Fibrillation Clinical Trial

— TraP-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392649
• Other study ID #: IRB17-1365
• Status: Completed
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: July 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Parasym
Tragus stimulation was done using the Parasym device.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Parasym Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.