Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)
1 other identifier
interventional
160
1 country
1
Brief Summary
This proposal aims to determine the effects of tVNS on autonomic tone, atrial substrate and neuromodulators in patients with paroxysmal atrial fibrillation (AF), investigate the chronic effects of optimal tVNS on AF burden in patients with paroxysmal AF over a 6-month period, compared with sham stimulation, and identify physiological and biochemical markers of response to chronic tVNS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2021
CompletedFirst Posted
Study publicly available on registry
December 29, 2021
CompletedStudy Start
First participant enrolled
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2026
ExpectedMarch 6, 2024
March 1, 2024
3.1 years
October 21, 2021
March 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Effects of tVNS on Atrial fibrillation burden
AF burden, defined as the percent of time spent in AF over the total monitoring period, will be determined be based on continuous monitoring with an Apple watch
6 months
Secondary Outcomes (3)
Effects of tVNS on neuropeptide Y
6 months
Effects of tVNS on Autonomic Tone
6 months
Effects of tVNS on P wave alternans
6 months
Study Arms (2)
Active TENS Stimulation
ACTIVE COMPARATORInactive TENS Stimulation
SHAM COMPARATORInterventions
Low-level, electrical stimulation of the outer ear (LLTS), using a transcutaneous electrical nerve stimulation (TENS) device.
Eligibility Criteria
You may qualify if:
- \. Paroxysmal atrial fibrillation
You may not qualify if:
- Sick sinus syndrome
- nd and 3rd degree AV block (without pacemaker), bifascicular block or prolonged (PR\>300ms) 1st degree AV block
- History of vagotomy
- Recurrent vasovagal syncope
- Left ventricular ejection fraction \< 40%
- Significant valvular disorder (i.e., prosthetic valve or hemodynamic significant valvular diseases)
- Recent stroke (\< 3 months)
- Myocardial infarction or hospitalization for heart failure (\< 3 months)
- Severe heart failure (NYHA Class IV)
- End stage kidney disease on dialysis
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stavros Stavrakis, MD
University of Oklahoma
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2021
First Posted
December 29, 2021
Study Start
September 14, 2022
Primary Completion
October 31, 2025
Study Completion (Estimated)
May 29, 2026
Last Updated
March 6, 2024
Record last verified: 2024-03