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

Completed

• Conditions: AF; Atrial fibrillation; 10007521

• Registration Number: NL-OMON50909
• Lead Sponsor: Reinier de Graaf Groep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-04-19
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 188

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

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Validation of the algorithm will result in the calculation of four statistical<br /><br>values. The sensitivity, specificity, F1-score and accuracy of the algorithm<br /><br>will be determined. These values form the outcome of the study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N.a.</p><br>