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Clinical Trials in Spain / NCT05565781
Recruiting Not applicable

Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke

NCT05565781 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Phase
Not applicable
Started
2022-03-28
Last updated
2025-04-04

Condition(s) studied

Paroxysmal Atrial FibrillationCryptogenic Stroke

Investigational drug(s) / intervention(s)

ECG smartwatchInsertable Cardiac Monitor (ICM)External ECG Monitoring

ECG smartwatch: Testing ECG smartwatch to detect AF or potential signs of AF

Insertable Cardiac Monitor (ICM): Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch)

External ECG Monitoring: Regular cardiac monitor for diagnosis of AF

Study summary

Stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (AF) being one of the most important. Prolonged ambulatory cardiac monitoring is recommended for detecting occult AF. Currently, there are non-invasive monitoring devices such as the textile Holter that have proven to be useful for monitoring for up to 30 days but not longer. Another alternative is smartwatches, although they must be validated for use in the elderly population who have had a stroke.

Eligibility

Sex
ALL
Min age
55 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Increased probability of detecting AF — Assessed throughout 1 year trial period
    To identify and compare prevalence rates of AF detection for the purpose of determine the clinical relevance or not of a prolonged screening process for AF. On the intervention group, patients will have a cardiac monitoring for up to 12 months. If AF is detected by ECG smartwatch, the ICM data will be analyzed by a cardiologist team and provide an ECG report to investigators in order to confirmed ECG smartwatch result.

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitari Vall d'Hebron Barcelona Catalonia Recruiting

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Other trials for the same condition

VOLT CE Mark Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05565781 on ClinicalTrials.gov ↗ ← All trials in Spain