Detection and Quantification of Atrial Fibrillation in High-Risk Patients Using a Smartwatch Wearable (Apple Watch) with a Photoplethysmographic sensor and ECG-functionality

Phase 2

Recruiting

• Conditions: arrhythmia; Atrial fibrillation; 10007521

• Registration Number: NL-OMON56124
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 436

Inclusion Criteria

- High risk, defined as patient ChadsVasc >=2 for men and or >=3 women at time of
eligibility screening
- Patient age >= 65 years at time of eligibility screening
- Possession of iPhone (5s or later) with iOS version 11.0 or later defined as
iPhone model/iOS version used to complete screening eligibility

Exclusion Criteria

- Diagnosis of Atrial fibrillation or Atrial Flutter
- Currently on anticoagulation therapy
- Cardiac implanted electronic device (Pacemaker, ICD)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the incidence of atrial fibrillation detected by<br /><br>the PPG sensor and Apple algorithm and diagnosed by a cardiologist<br /><br>(intervention group) or by standard care alone.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes are time to event, the initiation of therapies for AF,<br /><br>the number of patients with major adverse cardiovascular events, other<br /><br>arrhythmias than AF diagnosed by a cardiologist, predictors of AF and number of<br /><br>emergency department visits during the study period.</p><br>