Training and Validation of the Atrial Fibrillation Algorithm for Afi, a Novel Device for Arrythmia Diagnostics and Monitoring
- Conditions
- Atrial Fibrillation
- Registration Number
- NL-OMON29538
- Lead Sponsor
- Reinier de Graaf Gasthuis
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 166
Inclusion Criteria
= 18 years
Hospitalized for ECV to treat a priorly diagnosed AF
Prepared to use Afi
Willing and competent to give written IC
Exclusion Criteria
Implanted pacemaker, defibrillator or assist device.
Other heart rhythms than AF or SR based upon conventional ECG
Skin lesions, scars, or tattoos around the midsternal line of the thorax
Known allergy to one of Afi’s or the sticker’s components
Participation in another clinical trial
Already participated in trial 'Algorithm for Afi'
Pregnancy
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validation of AF detection algorithm
- Secondary Outcome Measures
Name Time Method