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Enrolling By Invitation
NCT05686330
Detection and Quantification of Atrial Fibrillation in High-risk Patients Using a Smartwatch Wearable (Apple Watch)
Conditions: Atrial Fibrillation, Wearable Electronic Devices
Sex: All
Ages: 65 Years – N/A
Phase: NA
Enrollment: 306
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Location: Netherlands
Summary
This is a Randomized Controlled trial to evaluate if continuous heart rate and -rhythm monitoring with a photoplethysmography (PPG) smartwatch wearable (Apple Watch series 5) can detect atrial fibrillation at an early stage in cardiac patients with a known high risk of developing AF (ChadsVasc score ≥ 2 men; ≥3 women; age ≥ 65).
In this monocenter, single arm, prospective randomized controlled trial the investigators will enroll 306 patients (153 per arm).
An absolute in between-group difference of 8.5% in diagnosing patients with new AF in favor of the interventional group during a six month study period is hypothesized.
Eligibility Criteria
Inclusion Criteria:Age ≥ 65 yearsChadsvasc score ≥2 for men and ≥ for women at the time of eligibility screeningWritten informed consent as documented by signature from the participantPossession of iPhone (6S or later)Exclusion Criteria:Diagnosis of atrial fibrillation or atrial flutterCurrently on anticoagulation therapyCardiac implanted electronic device (pacemaker, ICD)Smartwatch cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)Significant mental or cognitive impairment
Source: ClinicalTrials.gov (NCT05686330). StuddyBuddy aggregates publicly available trial information.