RecruitingNot ApplicableNCT06832579

SmartWatch-driven AF Detection in Stroke Patients

Pilot Study for SmartWatch-driven AF Detection in Stroke Patients

Sponsor

University of Leipzig

Enrollment

80 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)Ischemic Stroke Secondary Prevention ECG Monitoring Wearables

Summary

Unrecognized atrial fibrillation (AF) is a common cause of ischemic stroke. Implantable event monitors (ICM) are the gold standard for continuous heart rhythm monitoring but they have been implemented in very few patients after stroke due to high invasiveness and high costs. In this trial, patients with implanted ICMs (Medtronic Reveal LINQ Insertable Cardiac Monitor) will be randomized to use one of two wearables (1:1 Apple Watch or PulseOn) for continuous monitoring. The aim is to compare the probability of detecting an episode of AF with a wearable versus the gold standard ICM. Both groups will use the wearable for 12 weeks. If the wearables detect an arrhythmic pulse curve, this is communicated by vibration. By laying the other hand on the device, a 1-channel ECG is performed. ECG data will be transferred regularly to the CoreLab (Universityhospital Leipzig) for analysis. After 12 weeks, the patients will visit the site and answer questions regarding the usability, compliance and satisfaction with the wearables.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a consumer smartwatch can detect atrial fibrillation (an irregular heartbeat) as effectively as an implanted cardiac monitor in stroke patients. It is a sub-study within the larger Find-AF 2 trial, which aims to find undetected irregular heartbeats in people who have recently had a stroke. **You may be eligible if...** - You are already enrolled in the Find-AF 2 study - You have been assigned to the intervention arm and have an implanted cardiac monitor (Medtronic Reveal LINQ) - You have had a symptomatic ischemic stroke (a stroke caused by a blood clot) within the past 30 days - You are 60 years or older - You have little to no disability from the stroke (modified Rankin Scale score of 0–2 before the stroke) **You may NOT be eligible if...** - You are not part of the Find-AF 2 study - You do not meet the inclusion criteria of the Find-AF 2 parent study 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

DEVICEWearable

semi-continuous heart rhythm monitoring with Wearable

Locations(13)

RHÖN-KLINIKUM Campus Bad Neustadt Von-Guttenberg-Straße 11 Akutneurologie II - Stroke Unit - klinische Forschung

Bad Neustadt an der Saale, Germany

Evangelisches Klinikum Bethel, Clinic for Neurology

Bielefeld, Germany

Medizinische Fakultät Carl Gustav Carus Klinik und Poliklinik für Neurologie

Dresden, Germany

University of Essen, Clinic of Neurology

Essen, Germany

University of Göttingen, Clinic for Neurology

Göttingen, Germany

Bezirkskrankenhaus Günzburg Klinik für Neurologie und Neurologische Rehabilitation Ludwig-Heilmeyer-Straße 2

Günzburg, Germany

Krankenhaus Martha-Maria Halle-Dölau

Halle, Germany

Klinik für Neurologie Klinikum Ibbenbüren Große Str. 41

Ibbenbueren, Germany

University Hospital Leipzig, Clinic for Neurology

Leipzig, Germany

University of Mainz, Clinic for Neurology

Mainz, Germany

Johannes Wesling Klinikum Minden Universitätsklinik für Neurologie und Neurogeriatrie Hans-Nolte-Str. 1

Minden, Germany

Klinik für Neurologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Breslauer Str. 201

Nuremberg, Germany

Kliniken Südostbayern AG, Klinikum Traunstein

Traunstein, Germany

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NCT06832579

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