Vagal Nerve Stimulation for the Treatment of Persistent AF (VAST-AF)

Transcutaneous Vagal Nerve Stimulation for the Treatment of Persistent Atrial Fibrillation (VAST-AF): a Randomized, Controlled, Blinded, Monocentric, Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Vagal stimulation with the device tVNS from tVNS Technologies GmbH; Device: Sham stimulation with the device tVNS from tVNS Technologies GmbH

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 After that period the stimulation will be withdrawn and both groups will be compared.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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Swojanowsky, MD; Phone Number: +4906321/859-4001; Email: patrick.swojanowsky@marienhaus.de
• Study Contact Backup: Name: Hubertus von Korn, PhD; Phone Number: +4906321/859-4001; Email: hubertus.vonkorn@marienhaus.de

Study Locations

• Germany
  • Rhineland-Palatinate
    • Neustadt, Rhineland-Palatinate, Germany, 67434
      • Recruiting
      • Marienhaus Klinikum Hetzelstift
      • Contact: Patrick Swojanowsky, MD; Phone Number: +4963218590; Email: patrick.swojanowsky@marienhaus.de
      • Contact: Hubertus von Korn, MD, PhD; Phone Number: +4963218590; Email: hubertus.vonkorn@marienhaus.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verum group; Verum 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.	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.
Sham Comparator: Sham group; Sham 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of atrial fibrillation	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of symptoms due to atrial fibrillation	Assessed with the Atrial Fibrillation Severity Scale: AFSS V2	6 months
Significant alterations of parameters of the autonomous nervous system	Different parameters of the autonomous nervous system like heart rate variability and heart rate turbulence etc. are analyzed via ECG	6 months
Delay in recurrence of atrial fibrillation due to vagal stimulation	Comparison of the time interval to the first recurrence of atrial fibrillation between both groups	6 months

Collaborators and Investigators

• Sponsor: Krankenhaus Hetzelstift
• Collaborators: Johannes Gutenberg University Mainz; Deutsche Stiftung für Herzforschung
• Investigators: Principal Investigator: Patrick Swojanowsky, MD, Krankenhaus Hetzelstift

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Autonomic nervous system; Vagal stimulation; parasympathetic nervous system; Transcutaneous nerve stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Studie VAST-AF Swo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No