N/A
N=81
Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03392649 ↗Enrolled (actual)
81
Serious AEs
2.5%
Results posted
Aug 2022
Primary outcome: Primary: Time to the First Episode of Atrial Fibrillation (AF) >30 Seconds — 53.1; 52.2 hours — p=0.60
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Parasym (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to the First Episode of Atrial Fibrillation (AF) >30 Seconds |
53.1; 52.2 | 0.60 |
| PRIMARY Number of Participants Hospitalized for >5 Days |
25; 22 | 0.34 |
| SECONDARY Overall Atrial Fibrillation (AF) Burden |
24.7; 27.3 | 0.54 |
| SECONDARY Number of Participants With Rate Control Medications Used for AF |
17; 12 | 0.09 |
| SECONDARY Number of Participants With Antiarrhythmic Used to Treat AF |
16; 10 | 0.16 |
| SECONDARY Number of Participants With Inotropes Used for Blood Pressure Support During AF |
4; 2 | 0.67 |
| SECONDARY Number of Participants With Stroke or Transient Ischemic Attack (TIA) |
1; 1 | 1.0 |
| SECONDARY All-cause Mortality |
3; 0 | 0.12 |
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 Criteria
Inclusion Criteria
- 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
- Prior maze procedure for the treatment of AF
Data sourced from ClinicalTrials.gov (NCT03392649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.