Vagal Nerve Stimulation for the Treatment of Persistent AF

Last updated: November 6, 2023
Sponsor: Krankenhaus Hetzelstift
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Atrial Fibrillation

Treatment

Vagal stimulation with the device tVNS from tVNS Technologies GmbH

Sham stimulation with the device tVNS from tVNS Technologies GmbH

Clinical Study ID

NCT05833373
Studie VAST-AF Swo
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Persistent atrial fibrillation
  • Planned electric cardioversion
  • Sufficient oral anticoagulation for at least four weeks or
  • Absence of thrombus in transoesophageal echocardiography
  • Oral anticoagulation possible
  • Able to sign informed consent
  • Estimated life expectancy >1 year

Exclusion

Exclusion Criteria:

  • Permanent atrial fibrillation
  • Ablation therapy of supraventricular arrhythmias in the past
  • Missing anticoagulation respective missing rule out of thrombus
  • Inability to treat with oral anticoagulation
  • Latent or manifest hyperthyroidism
  • Acute infection with relevant clinical signs (temp > 38°C, significant elevatedC-reactive protein or white blood cells)
  • Inability to sign informed consent
  • Preexisting pacemaker or implantable cardioverter defibrillator
  • Recent vagal stimulation for other causes
  • Recent intolerance of transcutaneous vagal stimulation
  • Estimated life expectancy <1 year
  • Acute coronary syndrome
  • Haemodynamic instability
  • Valvular atrial fibrillation
  • Pregnancy

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Vagal stimulation with the device tVNS from tVNS Technologies GmbH
Phase:
Study Start date:
November 06, 2023
Estimated Completion Date:
December 20, 2025

Study Description

This study is an investigator-initiated, monocentric, randomised, controlled and blinded trial. Patients with persistent atrial fibrillation and planned electrical cardioversion will be included. The participants are randomised to one of two groups - the verum-group or the sham-group. Both groups receive a dedicated stimulation device that stimulates transcutaneously the Ramus auricularis of the Nervus vagus at the area of the Tragus. The verum-group will receive an effective stimulation and the sham-group an ineffective one. The aim of this trial is to evaluate whether this stimulation could reduce the recurrence of atrial fibrillation or not. Therefore daily stimulation of at least one hour will be performed for overall three months. After that period the stimulation will be withdrawn and both groups will be compared. Then, after another three months without stimulation both groups will be compared again to evaluate if a potential effect of the initial stimulation persists.

Connect with a study center

  • Marienhaus Klinikum Hetzelstift

    Neustadt, Rhineland-Palatinate 67434
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.