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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56124

Enrollment

436

Registered

2022-01-19

Start date

2022-11-17

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

arrhythmia Atrial fibrillation

Interventions

None listed

Eligibility

Age

65 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary study parameter is the incidence of atrial fibrillation detected by the PPG sensor and Apple algorithm and diagnosed by a cardiologist (intervention group) or by standard care alone.	—

Secondary

Measure	Time frame
The secondary outcomes are time to event, the initiation of therapies for AF, the number of patients with major adverse cardiovascular events, other arrhythmias than AF diagnosed by a cardiologist, predictors of AF and number of emergency department visits during the study period.	—

Countries

Netherlands

Outcome results