Status:
COMPLETED
Transcutaneous (Tragus) Vagal Nerve Stimulation for Post-op Afib
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
University of Oklahoma
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Patients undergoing cardiac surgery are at high risk of developing atrial fibrillation (AF), with estimated rates of 30-50% and occurs at approximately 2-4 days after surgery. The autonomic nervous sy...
Detailed Description
The trial will have two study arms: active tVNS vs. sham tVNS. Patients will be randomized to active tVNS vs. sham tVNS and will receive optimal post-op care in both arms. Active tVNS (Parasym device,...
Eligibility Criteria
Inclusion
- Patients scheduled to undergo coronary artery bypass surgery, major vascular/aneurysm repair requiring bypass, valvular replacement or repair, or both, for clinically indicated reasons.
- Age ≥ 18 years.
- Sinus rhythm at baseline.
- Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study
Exclusion
- Emergent surgery
- Anticipated amiodarone use
- Patients with permanent or persistent atrial fibrillation
- Planned concomitant atrial Maze procedure
- Complex congenital heart disease
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
- Left ventricular assist device or status post orthotopic heart or lung transplantation
- Unable or unwilling to comply with protocol requirements.
- Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
- Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker.
- Complete heart block or trifascicular block without an implantable pacemaker
- Recurrent vasovagal syncope
- Unilateral or bilateral vagotomy
- Chronic amiodarone use
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2024
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04514757
Start Date
September 20 2021
End Date
April 25 2024
Last Update
February 24 2025
Active Locations (2)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104