Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery

  • STATUS
    Recruiting
  • End date
    Jul 28, 2021
  • participants needed
    80
  • sponsor
    University of Chicago
Updated on 28 January 2021
arrhythmia
heart surgery
coronary artery bypass graft
paroxysmal atrial fibrillation

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 is a single-blind study where patients will be randomized tragus stimulation versus sham procedure and remain blinded to their treatment allocation. Both treatment options will utilize similar equipment, namely the use of alligator clips which will be placed on the tragus and earlobe of the right ear for patients. The distinction is only that in patients assigned to tragus stimulation, they will be initiated on therapy at the time of device placement.

Prior to cardiac surgery, the discomfort threshold of both left and righ tragus stimulation will be determined for all participating patients. Intermittent electrode signals, or microcurrents, are delivered at 20 Hz with100 sec pulse width with variable microampere (mA) output. The discomfort threshold is defined as the stimulation intensity in mA at which point patients experience discomfort. The stimulation intensity used in the study will be set just below the discomfort threshold. The clip will then be placed on the patient's ear at the end of surgery. After surgery is completed, the clip will then be removed and replaced on the opposite ear. Stimulation will then continue, one ear alternating with the other, every 4 hours for a total of 48 hours. It is possible that the threshold can change during the post-operative period. If the patient shows any sign of discomfort from stimulation, the intensity of stimulation will be reduced to a level at which signs of discomfort disappears.

Follow-up will be performed with a 14-day event monitor at the time of discharge. Electrocardiography (ECG) will be performed pre-procedure and prior to hospital discharge. Echocardiography will be assessed prior to study initiation and when clinically available in follow-up.

Details
Condition Arrhythmia, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Dysrhythmia
Treatment SaluSTIM, Parasym
Clinical Study IdentifierNCT03392649
SponsorUniversity of Chicago
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 89 yrs?
Gender: Male or Female
Do you have any of these conditions: Atrial Fibrillation (Pediatric) or Atrial Fibrillation or Arrhythmia or Dysrhythmia?
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

Exclusion Criteria

Patients 90 years of age, <18 years
Patients with known prior history of persistent or permanent AF
Atrial Fibrillation occurrence within the last 24 hours of procedure
Urgent or Emergency cases
Pregnant patients
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
Antiarrhythmics prior to surgery (Class I and Class III)
High degree atrioventricular block requiring temporary pacing
MAZE procedure
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