Status:
RECRUITING
SmartWatch-driven AF Detection in Stroke Patients
Lead Sponsor:
University of Leipzig
Conditions:
Atrial Fibrillation (AF)
Ischemic Stroke
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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...
Detailed Description
Patients with established continuous ICM monitoring from the prospective, randomized, multicenter study Find-AF 2 (NCT04371055) are recruited for this trial. Find-AF 2 is being carried out at Leipzig ...
Eligibility Criteria
Inclusion Criteria:
-
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):
i. 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.
ii. Age ≥ 60 years. iii. Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symtoms.
iv. 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)
Exclusion Criteria:
-
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
-
Exclusion criteria of the Find-AF 2 study (according to protocol version Final 4.0, dated 08.05.2024):
i. Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG.
ii. Current indication or contraindication for oral anticoagulation at randomisation.
iii. Intracerebral bleeding in medical history iv. Patient scheduled for ECG-monitoring lasting > 7 days (Holter-ECG, implanted loop recorder, etc.).
v. Implanted pacemaker device or cardioverter/defibrillator or implanted cardiac monitor.
vi. Patient not willing to be treated with oral anticoagulants vii. Carotid artery stenosis ipsilateral to the current ischemic stroke needing operation or intervention.
viii. History of carotid endarterectomy or percutaneous stent intervention of cerebral or cervical artery within the last 30 days.
ix. Life expectancy <1 year for reasons other than stroke (e.g. metastatic cancer).
x. 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
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06832579
Start Date
May 15 2025
End Date
March 1 2027
Last Update
November 19 2025
Active Locations (13)
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1
RHÖN-KLINIKUM Campus Bad Neustadt Von-Guttenberg-Straße 11 Akutneurologie II - Stroke Unit - klinische Forschung
Bad Neustadt an der Saale, Germany, 97616
2
Evangelisches Klinikum Bethel, Clinic for Neurology
Bielefeld, Germany, 33611
3
Medizinische Fakultät Carl Gustav Carus Klinik und Poliklinik für Neurologie
Dresden, Germany
4
University of Essen, Clinic of Neurology
Essen, Germany, 45147