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RECRUITING
NCT06832579
NA

SmartWatch-driven AF Detection in Stroke Patients

Sponsor: University of Leipzig

View on ClinicalTrials.gov

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

DEVICE

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