Training and Validation of the Atrial Fibrillation Algorithm for Afi, a Novel Device for Arrythmia Diagnostics and Monitoring.

Training and Validation of the Atrial Fibrillation Algorithm for Afi, a Novel Device for Arrythmia Diagnostics and Monitoring. - Algorithm for Afi

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50909

Enrollment

165

Registered

2021-05-21

Start date

2021-09-21

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AF Atrial fibrillation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: >= 18 years Hospitalized for electrical cardioversion to treat atrial fibrillation Prepared to use an experimental monitoring device Willing and competent to give written informed consent

Exclusion criteria

Exclusion criteria: Implanted pacemaker, defibrillator or assist device Other heart rhythm than atrial fibrillation or sinus rhythm Skin lesions or scars around the midsternal line of the thorax Tattoos around the midsternal line of the thorax Known allergy to one of the sticker components of the device Participation in another clinical trial Already participated in trial 'Algorithm for Afi' Pregnancy

Design outcomes

Primary

Measure	Time frame
Validation of the algorithm will result in the calculation of four statistical values. The sensitivity, specificity, F1-score and accuracy of the algorithm will be determined. These values form the outcome of the study.	—

Secondary

Measure	Time frame
N.a.	—

Countries

Netherlands

Outcome results