Vagal Nerve Stimulation for the Treatment of Persistent AF

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 6, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

December 20, 2025

Conditions
Atrial Fibrillation
Interventions
DEVICE

Vagal stimulation with the device tVNS from tVNS Technologies GmbH

The tVNS device is used to stimulate the Ramus auricularis of the Nervus vagus with a dedicated ear electrode for at least one hour per day on a daily basis. Stimulation frequency is 20Hz, pulsewidth is 200µs and amplitude is determined individually.

DEVICE

Sham stimulation with the device tVNS from tVNS Technologies GmbH

The tVNS device is used to stimulate the Ramus auricularis of the Nervus vagus with a dedicated ear electrode for at least one hour per day on a daily basis. In this case to perform a sham stimulation a non conducting ear electrode is used. The device is set to the same settings with a frequency of 20Hz, a pulsewidth of 200µs and an amplitude that is determined individually.

Trial Locations (1)

67434

RECRUITING

Marienhaus Klinikum Hetzelstift, Neustadt

All Listed Sponsors
collaborator

Deutsche Stiftung für Herzforschung

OTHER

collaborator

Johannes Gutenberg University Mainz

OTHER

lead

Krankenhaus Hetzelstift

OTHER