Status:
COMPLETED
Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Parasym Ltd.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-89 years
Phase:
NA
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 condi...
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 equipm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03392649
Start Date
March 9 2018
End Date
July 31 2021
Last Update
August 4 2022
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637