Using smartwatches and Holter monitors to find hidden atrial fibrillation in stroke patients
Official title: Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
Run by Hospital Universitari Vall d'Hebron Research Institute · NCT05565781 · Data updated 2026-11-12
This study is testing if using smartwatches and Holter monitors can help find hidden cases of atrial fibrillation in stroke patients aged 55 and older better than the usual 30-day monitoring.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Status | Recruiting |
| Started | March 28, 2022 |
| Main results expected | June 1, 2025 |
| Study ends | September 1, 2026 |
| Registry record updated | April 4, 2025 |
| Trial ID | NCT05565781 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 55 and older who have experienced a cryptogenic stroke and meet specific diagnostic criteria.
✕Probably not a fit
Patients with known sources of stroke or those with certain cardiac devices, like pacemakers, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to determine if long-term monitoring with wearable devices, such as smartwatches and external Holter monitors, can detect more cases of occult atrial fibrillation (AF) in patients who have experienced a cryptogenic stroke compared to traditional 30-day monitoring. The study will involve patients aged 55 and older who have had a stroke, and will assess the effectiveness of smartwatches against insertable cardiac monitors. Additionally, it will evaluate patient adherence to using these devices and identify predictors of long-term AF and vascular events.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of atrial fibrillation, potentially reducing the risk of recurrent strokes in patients.
How similar studies have gone: Previous studies have shown promise in using wearable technology for cardiac monitoring, but this specific long-term approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater to or equal to 55 years * Patients with diagnosis of cryptogenic stroke after a basic study that included neuroimaging, extra/intracranial vascular evaluation, 24-hour monitoring, and echocardiogram * Patients with acute cortical infarction with the presence of intracranial occlusion (preferably) * Modified Rankin Scale (mRS) lower to 4 Exclusion Criteria: * Diagnosis of lacunar infarction or transient ischemic attack (TIA) * Diagnosis of stroke of known source: atherothrombotic due to moderate or severe symptomatic extra/intracranial stenosis, major cardioembolic cause (atrial fibrillation, anterior or apical ventricular akinesis, causal PFO, post-AMI, flutter or mitral stenosis), unusual cause (thrombophilia, arterial dissection symptomatic, toxic) * Use of pacemakers * Circumstances that may preclude the clinical follow-up or reduce the possibilities of obtaining data to achieve the objectives of the study and/or limit contact with the investigator (for example, transfer to a social health center) * Unwillingness to the use of cardiac monitoring wearable devices * Not understanding study procedures
Where it's running
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Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.