Atrial FibrillationVAST-AFNCT05833373
Vagal Nerve Stimulation for the Treatment of Persistent AF
A study testing Vagal stimulation with the device tVNS from tVNS Technologies GmbH in people with Atrial Fibrillation, run by Krankenhaus Hetzelstift at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Vagal stimulation with the device tVNS from tVNS Technologies GmbH
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 6 Nov 2023to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Marienhaus Klinikum Hetzelstift
Neustadt, Rhineland-Palatinate, 67434
Patrick Swojanowsky, MD, +4963218590, patrick.swojanowsky@marienhaus.de
Hubertus von Korn, MD, PhD, +4963218590, hubertus.vonkorn@marienhaus.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Vagal stimulation with the device tVNS from tVNS Technologies GmbH, Sham stimulation with the device tVNS from tVNS Technologies GmbH
- Keywords
- Atrial Fibrillation, Vagal stimulation, Transcutaneous nerve stimulation, Autonomic nervous system, parasympathetic nervous system
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal stimulation with the device tVNS from tVNS Technologies GmbHDevice
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 stimulation with the device tVNS from tVNS Technologies GmbHDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham stimulation with the device tVNS from tVNS Technologies GmbH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Reduction of symptoms due to atrial fibrillation
Assessed with the Atrial Fibrillation Severity Scale: AFSS V2
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start6 Nov 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Hetzelstift
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung, Johannes Gutenberg University Mainz
- Responsible party
- Principal investigator, Dr. Patrick Swojanowsky, Krankenhaus Hetzelstift
- Investigators
- Patrick Swojanowsky, MD, Principal investigator, Krankenhaus Hetzelstift
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833373
- Sponsor's protocol ID
- Studie VAST-AF Swo
- Acronym
- VAST-AF
- Status last verified
- Nov 2023
- First submitted
- 17 Apr 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Vagal Nerve Stimulation for the Treatment of Persistent Atrial Fibrillation (VAST-AF): a Randomized, Controlled, Blinded, Monocentric, Clinical Trial
- ClinicalTrials.gov ID
- NCT05833373
- Acronym / sponsor ID
- VAST-AF / Studie VAST-AF Swo
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Vagal stimulation, Transcutaneous nerve stimulation, Autonomic nervous system, parasympathetic nervous system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Krankenhaus HetzelstiftUniversity, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung, Johannes Gutenberg University Mainz
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum group | Experimental | Device: Vagal stimulation with the device tVNS from tVNS Technologies GmbHVerum 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. |
| Sham group | Sham comparator | Device: Sham stimulation with the device tVNS from tVNS Technologies GmbHSham 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Persistent atrial fibrillation
- Planned electric cardioversion
- Sufficient oral anticoagulation for at least four weeks or
- Absence of thrombus in transoesophageal echocardiography
- Oral anticoagulation possible
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagal stimulation with the device tVNS from tVNS Technologies GmbHThe 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. | Device | Verum group |
| Sham stimulation with the device tVNS from tVNS Technologies GmbHThe 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. | Device | Sham group |
Primary outcome
Recurrence of atrial fibrillation
Time frame: 6 months
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.
3 secondary outcomes
Reduction of symptoms due to atrial fibrillation
Time frame: 6 months
Significant alterations of parameters of the autonomous nervous system
Time frame: 6 months
Delay in recurrence of atrial fibrillation due to vagal stimulation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Swojanowsky, MD principal investigator
Krankenhaus Hetzelstift
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal stimulation with the device tVNS from tVNS Technologies GmbH in people with Atrial Fibrillation, run by Krankenhaus Hetzelstift at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Swojanowsky, MD (+4906321/859-4001, patrick.swojanowsky@marienhaus.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial fibrillation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.