RECRUITING

Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)

Quick Facts

Study Start:2022-09-14

Study Completion:2026-05-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05172765

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Paroxysmal atrial fibrillation	1. Sick sinus syndrome 2. 2nd and 3rd degree AV block (without pacemaker), bifascicular block or prolonged (PR\>300ms) 1st degree AV block 3. History of vagotomy 4. Recurrent vasovagal syncope 5. Left ventricular ejection fraction \< 40% 6. Significant valvular disorder (i.e., prosthetic valve or hemodynamic significant valvular diseases) 7. Recent stroke (\< 3 months) 8. Myocardial infarction or hospitalization for heart failure (\< 3 months) 9. Severe heart failure (NYHA Class IV) 10. End stage kidney disease on dialysis 11. Pregnancy

Inclusion Criteria

Exclusion Criteria

1. Paroxysmal atrial fibrillation

1. Sick sinus syndrome
2. 2nd and 3rd degree AV block (without pacemaker), bifascicular block or prolonged (PR\>300ms) 1st degree AV block
3. History of vagotomy
4. Recurrent vasovagal syncope
5. Left ventricular ejection fraction \< 40%
6. Significant valvular disorder (i.e., prosthetic valve or hemodynamic significant valvular diseases)
7. Recent stroke (\< 3 months)
8. Myocardial infarction or hospitalization for heart failure (\< 3 months)
9. Severe heart failure (NYHA Class IV)
10. End stage kidney disease on dialysis
11. Pregnancy

Contacts and Locations

Study Contact

Natalia Wells-Serrano

CONTACT

405-271-4742

Natalia-WellsSerrano@ouhsc.edu

Principal Investigator

Stavros Stavrakis, MD

PRINCIPAL_INVESTIGATOR

University of Oklahoma

Study Locations (Sites)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Collaborators and Investigators

Sponsor: University of Oklahoma

Stavros Stavrakis, MD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-14

Study Completion Date2026-05-29

Study Record Updates

Study Start Date2022-09-14

Study Completion Date2026-05-29

Terms related to this study

Additional Relevant MeSH Terms

Paroxysmal Atrial Fibrillation