Using smartwatches to detect atrial fibrillation in high-risk patients
Enhanced Detection and Quickened Diagnosis of Atrial Fibrillation Using the Apple Watch: A Randomised Controlled Trial (EQUAL Study)
This study is testing if using an Apple Watch to monitor heart rhythm can help older patients at high risk for atrial fibrillation find new cases of the condition better than regular check-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 306 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 2 sites (Amsterdam, Noord-Holland and 1 other locations) |
| Trial ID | NCT05686330 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of continuous heart rate and rhythm monitoring using an Apple Watch in detecting atrial fibrillation (AF) in patients aged 65 and older with a high risk of developing AF. The study involves 306 participants who will be randomized into two groups: one receiving the smartwatch for monitoring and the other receiving standard care. The primary goal is to determine if the smartwatch can identify new cases of AF more effectively than standard care alone over a six-month period. Secondary outcomes include the timing of the first AF episode and the initiation of therapies for AF.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older with a ChadsVasc score of 2 or higher for men and 3 or higher for women.
Not a fit: Patients who already have a diagnosis of atrial fibrillation or are currently on anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and treatment of atrial fibrillation, potentially reducing the risk of stroke and other complications in high-risk patients.
How similar studies have performed: Other studies have shown promise in using wearable technology for monitoring heart conditions, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 65 years * Chadsvasc score ≥2 for men and ≥ for women at the time of eligibility screening * Written informed consent as documented by signature from the participant * Possession of iPhone (6S or later) Exclusion Criteria: * Diagnosis of atrial fibrillation or atrial flutter * Currently on anticoagulation therapy * Cardiac implanted electronic device (pacemaker, ICD) * Smartwatch cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other) * Significant mental or cognitive impairment
Where this trial is running
Amsterdam, Noord-Holland and 1 other locations
- Cardiology Center of the Netherlands — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Spaarne Gasthuis — Haarlem, Noord-Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Nicole Jennifer van Steijn, MD
- Email: n.vansteijn@cardiologiecentra.nl
- Phone: 0031616680899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.