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SmartWatch-driven AF Detection in Stroke Patients
Sponsor: University of Leipzig
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.
Official title: Pilot Study for SmartWatch-driven AF Detection in Stroke Patients
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-05-15
Completion Date
2027-03
Last Updated
2025-11-19
Healthy Volunteers
No
Interventions
Wearable
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