RecruitingNot ApplicableNCT05172765

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

Sponsor

University of Oklahoma

Enrollment

160 participants

Start Date

Sep 14, 2022

Study Type

INTERVENTIONAL

Conditions

Paroxysmal Atrial Fibrillation

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.

Eligibility

Min Age: 21 YearsMax Age: 90 Years

Inclusion Criteria1

\. Paroxysmal atrial fibrillation

Exclusion Criteria11

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

Interventions

DEVICETranscutaneous Electrical Nerve Stimulation Device

Low-level, electrical stimulation of the outer ear (LLTS), using a transcutaneous electrical nerve stimulation (TENS) device.

Locations(1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

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