Transcutaneous Vagal Nerve Stimulation for the Treatment ofPersistent Atrial Fibrillation (VAST-AF): a Randomized, Controlled,Blinded, Monocentric, Clinical Trial
- Conditions
- I48.1Persistent atrial fibrillation
- Registration Number
- DRKS00031382
- Lead Sponsor
- Marienhaus Klinikum Hetzelstift
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Reduction of symptoms due to atrial fibrillation