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Vagal Nerve Stimulation for the Treatment of Persistent AF

Not Applicable
Recruiting
Conditions
Atrial Fibrillation
Interventions
Device: Sham stimulation with the device tVNS from tVNS Technologies GmbH
Device: Vagal stimulation with the device tVNS from tVNS Technologies GmbH
Registration Number
NCT05833373
Lead Sponsor
Krankenhaus Hetzelstift
Brief 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.

Detailed 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 After that period the stimulation will be withdrawn and both groups will be compared.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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
120
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 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 elevated C-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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sham groupSham stimulation with the device tVNS from tVNS Technologies GmbHSham group with ineffective vagal stimulation. Same stimulation procedure like in the verum group with the stimulation device tVNS from tVNS Technologies GmbH. The stimulation is performed with an ear-electrode at the Tragus, too. Minimal stimulation duration is 1 hour per day for 3 months, but with a non conducting ear electrode.
Verum groupVagal stimulation with the device tVNS from tVNS Technologies GmbHVerum group - active vagal stimulation with the stimulation device tVNS from tVNS Technologies GmbH. The stimulation is performed with an ear-electrode at the Tragus. Minimal stimulation duration is 1 hour per day for 3 months.
Primary Outcome Measures
NameTimeMethod
Recurrence of atrial fibrillation6 months

Defined as an episode of atrial fibrillation \>30 seconds that is detected with ECG, holter-ECG or wearable (i.e. Apple Watch). ECGs are performed during follow-up visits or could be conducted by an other hospital or during an ambulatory medical contact.

Secondary Outcome Measures
NameTimeMethod
Delay in recurrence of atrial fibrillation due to vagal stimulation6 months

Comparison of the time interval to the first recurrence of atrial fibrillation between both groups

Reduction of symptoms due to atrial fibrillation6 months

Assessed with the Atrial Fibrillation Severity Scale: AFSS V2

Significant alterations of parameters of the autonomous nervous system6 months

Different parameters of the autonomous nervous system like heart rate variability and heart rate turbulence etc. are analyzed via ECG

Trial Locations

Locations (1)

Marienhaus Klinikum Hetzelstift

🇩🇪

Neustadt, Rhineland-Palatinate, Germany

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