Vagal nerve stimulation to reduce atrial fibrillation recurrence
Transcutaneous Vagal Nerve Stimulation for the Treatment of Persistent Atrial Fibrillation (VAST-AF): a Randomized, Controlled, Blinded, Monocentric, Clinical Trial
This study is testing if a device that stimulates the vagus nerve can help people with persistent atrial fibrillation have fewer episodes of the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Krankenhaus Hetzelstift Academic / other |
| Locations | 1 site (Neustadt, Rhineland-Palatinate) |
| Trial ID | NCT05833373 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether transcutaneous vagal nerve stimulation can reduce the recurrence of persistent atrial fibrillation. Participants will use a dedicated stimulation device for at least one hour daily over three months, with one group receiving effective stimulation and the other receiving a sham treatment. The study is randomized and blinded, ensuring that neither participants nor researchers know which treatment is being administered. After the treatment period, the groups will be compared to assess the effectiveness of the stimulation.
Who should consider this trial
Good fit: Ideal candidates include individuals with persistent atrial fibrillation who are scheduled for electrical cardioversion and can manage oral anticoagulation.
Not a fit: Patients with permanent atrial fibrillation or those unable to undergo oral anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option to reduce the recurrence of atrial fibrillation in patients.
How similar studies have performed: While the approach of vagal nerve stimulation is being explored, this specific application for atrial fibrillation is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Neustadt, Rhineland-Palatinate
- Marienhaus Klinikum Hetzelstift — Neustadt, Rhineland-Palatinate, Germany (Recruiting)
Study contacts
- Principal investigator: Patrick Swojanowsky, MD — Krankenhaus Hetzelstift
- Study coordinator: Patrick Swojanowsky, MD
- Email: patrick.swojanowsky@marienhaus.de
- Phone: +4906321/859-4001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.