Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery

NCT03392649 | Completed Results FDA Device

• 1 other identifier: IRB17-1365
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Postoperative Atrial Fibrillation; Tragus Stimulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Overall Atrial Fibrillation (AF) Burden

  From end of surgery to end of hospitalization, up to 1 month.

• Number of Participants With Rate Control Medications Used for AF

  From end of surgery to end of hospitalization, up to 1 month.

• Number of Participants With Antiarrhythmic Used to Treat AF

  From end of surgery to end of hospitalization, up to 1 month.

• Number of Participants With Inotropes Used for Blood Pressure Support During AF

  From end of surgery to end of hospitalization, up to 1 month.

• Number of Participants With Stroke or Transient Ischemic Attack (TIA)

  From end of surgery to end of hospitalization, up to 1 month.

Study Arms (2)

Sham Group

NO INTERVENTION

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.

Stimulation Group

EXPERIMENTAL

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

Interventions

Parasym DEVICE

Tragus stimulation was done using the Parasym device.

Stimulation Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Prior maze procedure for the treatment of AF

Sponsors & Collaborators

• University of Chicago: lead
• Parasym Ltd.: collaborator

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Gaurav Upadhyay
• Organization: Univerisity of Chicago Medicine

gupadhyay@medicine.bsd.uchicago.edu

773-702-9461

Study Officials

• Gaurav A. Upadhyay, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Roderick Tung, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 8, 2018
• Study Start: March 9, 2018
• Primary Completion: July 30, 2021
• Study Completion: July 31, 2021
• Last Updated: August 4, 2022
• Results First Posted: August 4, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)