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

Recruiting now · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation, Cryptogenic Stroke

In brief

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.

Key facts

Study ID

NCT05565781

Run by

Hospital Universitari Vall d'Hebron Research Institute

People needed

100

Starts

2022-03-28

Expected to finish

2026-09-01

Last updated by the study team

2025-04-04

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Hospital Universitari Vall d'Hebron — Barcelona, Catalonia, Spain (enrolling)

Full record on ClinicalTrials.gov

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