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

Krankenhaus Hetzelstift

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: Sham stimulation with the device tVNS from tVNS Technologies GmbH; Device: Vagal stimulation with the device tVNS from tVNS Technologies GmbH

Study type: Interventional

Funder types: Other

Identifiers

NCT05833373

Studie VAST-AF Swo

Details and patient eligibility

About

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.

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 After that period the stimulation will be withdrawn and both groups will be compared.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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Verum group

Experimental group

Description:

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.

Treatment:

Device: Vagal stimulation with the device tVNS from tVNS Technologies GmbH

Sham group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham stimulation with the device tVNS from tVNS Technologies GmbH