Vagal Nerve Stimulation for the Treatment of Persistent AF

NCT05833373 | Unknown

• 1 other identifier: Studie VAST-AF Swo
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Vagal stimulation; Transcutaneous nerve stimulation; Autonomic nervous system; parasympathetic nervous system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Reduction of symptoms due to atrial fibrillation

  6 months

• Significant alterations of parameters of the autonomous nervous system

  6 months

• Delay in recurrence of atrial fibrillation due to vagal stimulation

  6 months

Study Arms (2)

Verum group

EXPERIMENTAL

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

Sham group

SHAM COMPARATOR

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

Interventions

Vagal stimulation with the device tVNS from tVNS Technologies GmbH DEVICE

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.

Verum group

Sham stimulation with the device tVNS from tVNS Technologies GmbH DEVICE

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.

Sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Krankenhaus Hetzelstift: lead
• Deutsche Stiftung für Herzforschung: collaborator
• Johannes Gutenberg University Mainz: collaborator

Study Sites (1)

Marienhaus Klinikum Hetzelstift

Neustadt, Rhineland-Palatinate, 67434, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Swojanowsky, MD

  Krankenhaus Hetzelstift

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Swojanowsky, MD

CONTACT

+4906321/859-4001; patrick.swojanowsky@marienhaus.de

Hubertus von Korn, PhD

CONTACT

+4906321/859-4001; hubertus.vonkorn@marienhaus.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All participants are randomized 1:1 to either the verum- or the sham-group. Both device look similar and are used in the same way so the participants are blinded. This is achieved with a conducting and a non-conducting ear electrode. The care provider and the investigator is blinded as well. The researcher who randomises the patient is strictly separated from the investigator who is responsible for the follow-up. Only after the patient completed the last follow-up the outcome assessor will match the patient data with the affiliation to either the sham- or the verum-group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Patrick Swojanowsky

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 27, 2023
• Study Start: November 6, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 20, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)