I48.1
Conditions
Interventions
Group 1: 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 dura
Sponsors
Marienhaus Klinikum Hetzelstift
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Persistend atrial fibrillation Planned electric cardioversion Sufficient oral anticoagulation for at least four weeks or Absence of thrombus in TEE Oral anticoagulation possible Able to sign informed consent Estimated life expectancy >1 year
Exclusion criteria
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 CRP or WBC) Inability to sign informed consent Preexisting pacemaker or ICD 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reccurence of atrial fibrillation after cardioversion, 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of symptoms due to atrial fibrillation | — |
Countries
Germany
Contacts
Public ContactPatrick Swojanowsky
Marienhaus Klinikum Hetzelstift
Outcome results
None listed