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Vagal Nerve Stimulation for the Treatment of Persistent AF

NCT05833373 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-11-07

No results posted yet for this study

Summary

The goal of this clinical trial is to answer the question whether a transcutaneous stimulation of a certain nerve (Nervus vagus) with a dedicated device reduces the recurrence of the heart rhythm disorder atrial fibrillation.

Participants will receive a dedicated nerval stimulation device and will treat themselves on a daily basis for at least an hour per day. Treatment will last for 3 months. Researchers will compare this group with a similar group that uses an ineffective device. Both researcher and patients will be blinded so they do not know which device they will be using.

Conditions

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.

Sponsors & Collaborators

  • Deutsche Stiftung für Herzforschung

    collaborator OTHER

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Krankenhaus Hetzelstift

    lead OTHER

Principal Investigators

  • Patrick Swojanowsky, MD · Krankenhaus Hetzelstift

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2025-11-30
Completion
2025-12-20

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05833373 on ClinicalTrials.gov