RecruitingNot ApplicableNCT05565781

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

Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke


Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

100 participants

Start Date

Mar 28, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a consumer smartwatch with a traditional external heart monitor (Holter monitor) to detect atrial fibrillation (an irregular heart rhythm) in stroke survivors where the cause of the stroke is unknown. Finding hidden atrial fibrillation after a stroke is important because it changes treatment — these patients need blood thinners to prevent another stroke. **You may be eligible if...** - You are 55 years of age or older - You have been diagnosed with a cryptogenic stroke (a stroke where no clear cause was found) after a standard workup - Your disability from the stroke is mild (Modified Rankin Scale score below 4) **You may NOT be eligible if...** - Your stroke was a small lacunar infarct or a TIA (mini stroke) - A clear cause was already found for your stroke (known atrial fibrillation, significant artery narrowing, blood clot from the heart, or a clotting disorder) - You already have a pacemaker - You are unwilling to wear cardiac monitoring devices - Your circumstances would make follow-up difficult Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEECG smartwatch

Testing ECG smartwatch to detect AF or potential signs of AF

DEVICEInsertable Cardiac Monitor (ICM)

Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch)

DEVICEExternal ECG Monitoring

Regular cardiac monitor for diagnosis of AF


Locations(1)

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, Spain

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NCT05565781


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