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NCT06832579Completed

SmartWatch-driven AF Detection in Stroke Patients

Pilot Study for SmartWatch-driven AF Detection in Stroke Patients

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
84 (actual)
First submitted
13 Feb 2025
Start date
15 May 2025
Primary completion date
29 Jun 2026
Lead sponsor
University of Leipzig
NCT number
NCT06832579

What you commit to

  • Study type: Interventional
  • Participants enrolled: 84
  • From 15 May 2025 to the primary completion date, 29 Jun 2026
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient not willing to be treated with oral anticoagulants vii. Carotid artery stenosis ipsilateral to the current ischemic stroke needing operation or intervention.

Other illness

  • Exclusion criteria of the Find-AF 2 study (according to protocol version Final 4.0, dated 08.05.2024):
    • Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG.
  • Intracerebral bleeding in medical history iv. Patient scheduled for ECG-monitoring lasting \> 7 days (Holter-ECG, implanted loop recorder, etc.).
  • Implanted pacemaker device or cardioverter/defibrillator or implanted cardiac monitor.
  • History of carotid endarterectomy or percutaneous stent intervention of cerebral or cervical artery within the last 30 days.
  • Life expectancy \<1 year for reasons other than stroke (e.g. metastatic cancer).
  • Patients under legal supervision or guardianship xi. Psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire due to dementia, language difficulties, ... ) or participate in the required tests xii. Participation in other randomized interventional trials xiii. Suspected lack of compliance

Other

  • Expiration of the battery of the event recorder in \<3 months
  • No in ICM data transmission possible (e. g. missing compliance)
  • Poor ECG data quality according to core lab evaluation (e.g. permanent oversensing), which prevents meaningful evaluation of the event recorder data
  • Current indication or contraindication for oral anticoagulation at randomisation.

Who the study is looking for

  • Study participation in Find-AF 2
  • Randomization in the intervention arm of the Find-AF 2 study and presence of an implanted event recorder (Medtronic Reveal LINQTM Insertable Cardiac Monitor)
  • Signed informed consent
  • All inclusion criteria of the Find-AF 2 study are met (according to protocol version Final 4.0, dated 08.05.2024):
    • Recent symptomatic ischemic stroke within the last 30 days (sudden focal neurologic deficit lasting \> 24 h consistent with the territory of a cerebral artery) If the neurologic deficit lasted \< 24 h a corresponding lesion\* on brain imaging is needed.
  • Age ≥ 60 years. iii. Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symtoms.
  • Written informed consent
    • \* Corresponding lesion can be an acute lesion on diffusion-weighted magnetic resonance imaging, native computed tomography (CT) or CT perfusion imaging or a recent occlusion or intracranial thrombus on angiography (CTA, MRA, DSA)

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
RHÖN-KLINIKUM Campus Bad Neustadt Von-Guttenberg-Straße 11 Akutneurologie II - Stroke Unit - klinische Forschung
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Bad Neustadt an der SaaleGermanyUnknown status
Evangelisches Klinikum Bethel, Clinic for Neurology
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BielefeldGermanyUnknown status
Medizinische Fakultät Carl Gustav Carus Klinik und Poliklinik für Neurologie
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DresdenGermanyUnknown status
Universitätklinikum Erlangen Neurologische Klinik, Schwabachanlage 6
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ErlangenGermanyUnknown status
University of Essen, Clinic of Neurology
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EssenGermanyUnknown status
University of Göttingen, Clinic for Neurology
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GöttingenGermanyUnknown status
Krankenhaus Martha-Maria Halle-Dolau
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HalleGermanyUnknown status
Klinik für Neurologie Klinikum Ibbenbüren Große Str. 41
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IbbenbuerenGermanyUnknown status
University Hospital Leipzig, Clinic for Neurology
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LeipzigGermanyUnknown status
University of Mainz, Clinic for Neurology
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MainzGermanyUnknown status
Johannes Wesling Klinikum Minden Universitätsklinik für Neurologie und Neurogeriatrie Hans-Nolte-Str. 1
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MindenGermanyUnknown status
Klinik für Neurologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Breslauer Str. 201
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NurembergGermanyUnknown status
Kliniken Südostbayern AG, Klinikum Traunstein
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TraunsteinGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.