SmartWatch-driven AF Detection in Stroke Patients

Launched by UNIVERSITY OF LEIPZIG · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how effective smartwatches are at detecting a heart condition called atrial fibrillation (AF) in patients who have recently had a stroke. Atrial fibrillation can lead to more strokes, so finding it early is important. In this study, patients who already have a special heart monitor implanted in their body will use either an Apple Watch or a PulseOn smartwatch for 12 weeks. The goal is to see if these wearables can find AF just as well as the implanted monitor, which is usually the best way to check heart rhythms but can be expensive and invasive.

To be eligible for the trial, patients must have had a stroke in the last 30 days and be at least 60 years old. They should also have a low level of disability before the stroke. If they join, they will wear the smartwatch, which will alert them if it detects any unusual heart activity, and they can perform a simple heart test using the watch. After the 12 weeks, participants will visit the study site to share their experiences with the smartwatch, including how easy it was to use and how satisfied they were with it. This trial is currently not recruiting participants yet, but it aims to help improve heart monitoring for stroke patients in the future.

Gender

ALL

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