Vagal Nerve Stimulation for the Treatment of Persistent AF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2025-12-20

Brief Summary

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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.

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Detailed Description

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 After that period the stimulation will be withdrawn and both groups will be compared.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

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Vagal stimulation with the device tVNS from tVNS Technologies GmbH

Intervention Type 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.

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.

Group Type SHAM_COMPARATOR

Sham stimulation with the device tVNS from tVNS Technologies GmbH

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No