Transcutaneous (Tragus) Vagal Nerve Stimulation for Post-op Afib
Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Aug 12, 2020
Trial Information
Current as of June 17, 2025
Completed
Keywords
ClinConnect Summary
This clinical trial is studying a method called transcutaneous vagus nerve stimulation (tVNS) to help prevent atrial fibrillation (AF) in patients who have recently undergone heart surgery. Atrial fibrillation is a common heart rhythm problem that can occur after surgery, affecting about 30-50% of patients. The goal of this study is to see if tVNS can reduce the chances of developing AF and shorten hospital stays after surgery by calming the heart and reducing inflammation.
To participate in this trial, patients must be adults aged 18 or older who are scheduled for specific types of heart surgeries, such as bypass surgery or valve repair, and must have a normal heart rhythm before surgery. The study is currently looking for participants who are willing to follow all the study guidelines. Those with certain medical conditions or who are pregnant cannot participate. If you join the study, you can expect to receive tVNS treatment and help researchers learn more about its effects on heart health after surgery.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Patients scheduled to undergo coronary artery bypass surgery, major vascular/aneurysm repair requiring bypass, valvular replacement or repair, or both, for clinically indicated reasons.
- • 2. Age ≥ 18 years.
- • 3. Sinus rhythm at baseline.
- • 4. Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study
- Exclusion Criteria:
- • 1. Emergent surgery
- • 2. Anticipated amiodarone use
- • 3. Patients with permanent or persistent atrial fibrillation
- • 4. Planned concomitant atrial Maze procedure
- • 5. Complex congenital heart disease
- • 6. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
- • 7. Left ventricular assist device or status post orthotopic heart or lung transplantation
- • 8. Unable or unwilling to comply with protocol requirements.
- • 9. Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
- • 10. Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker.
- • 11. Complete heart block or trifascicular block without an implantable pacemaker
- • 12. Recurrent vasovagal syncope
- • 13. Unilateral or bilateral vagotomy
- • 14. Chronic amiodarone use
About University Of California, Los Angeles
The University of California, Los Angeles (UCLA) is a prestigious academic institution renowned for its commitment to research and innovation in the biomedical field. As a clinical trial sponsor, UCLA leverages its cutting-edge facilities, expert faculty, and collaborative environment to advance medical knowledge and improve patient care. The university is dedicated to conducting rigorous clinical research that adheres to the highest ethical standards, aiming to translate scientific discoveries into effective therapies and interventions. Through its diverse array of clinical trials, UCLA seeks to address critical health challenges while fostering the development of future healthcare leaders.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Oklahoma City, Oklahoma, United States
Patients applied
Trial Officials
Jonathan Ho, MD
Principal Investigator
University of California, Los Angeles
Marmar Vaseghi, MD
Principal Investigator
University of California, Los Angeles
Stavros Stavrakis, MD, PhD
Principal Investigator
University of Oklahoma
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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