Clinical trial Recruiting at 1 site Interventional Ages 55 and up

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.

More Paroxysmal Atrial Fibrillation trials

Quick facts

Study typeInterventional
Ages55 Years and up
SexAll
Enrollment100 (estimated)
SponsorHospital Universitari Vall d'Hebron Research Institute
Academic / other
Locations1 site (Barcelona, Catalonia)
StatusRecruiting
StartedMarch 28, 2022
Main results expectedJune 1, 2025
Study endsSeptember 1, 2026
Registry record updatedApril 4, 2025
Trial IDNCT05565781 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

  • Hospital Universitari Vall d'Hebron
    Barcelona, Catalonia, Spain
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.