Wearable devices for detecting atrial fibrillation in stroke patients
Pilot Study for SmartWatch-driven AF Detection in Stroke Patients
This study tests whether wearable devices like the Apple Watch can better detect atrial fibrillation in stroke patients compared to their regular heart monitors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 8 sites (Bielefeld and 7 other locations) |
| Trial ID | NCT06832579 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of wearable devices, specifically the Apple Watch and PulseOn, in detecting atrial fibrillation (AF) in patients who have had a recent ischemic stroke and have an implanted cardiac monitor. Patients will be randomized to use one of the two wearables for continuous monitoring over a 12-week period. The study aims to compare the detection rates of AF episodes between the wearables and the standard implantable cardiac monitor. Data collected from the wearables will be analyzed to assess usability and compliance.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 and older who have experienced a recent ischemic stroke and have an implanted Medtronic Reveal LINQ Insertable Cardiac Monitor.
Not a fit: Patients who do not meet the inclusion criteria of the Find-AF 2 study or those with significant disabilities prior to their stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more accessible method for continuous AF monitoring in stroke patients.
How similar studies have performed: Other studies have shown promise in using wearables for AF detection, but this specific approach is novel in the context of post-stroke monitoring.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bielefeld and 7 other locations
- Evangelisches Klinikum Bethel, Clinic for Neurology — Bielefeld, Germany (Recruiting)
- University of Essen, Clinic of Neurology — Essen, Germany (Not_yet_recruiting)
- University of Göttingen, Clinic for Neurology — Göttingen, Germany (Not_yet_recruiting)
- Krankenhaus Martha-Maria Halle-Dölau — Halle, Germany (Not_yet_recruiting)
- University Hospital Leipzig, Clinic for Neurology — Leipzig, Germany (Recruiting)
- University of Mainz, Clinic for Neurology — Mainz, Germany (Not_yet_recruiting)
- Klinikum Nürnberg — Nürnberg, Germany (Not_yet_recruiting)
- Kliniken Südostbayern AG, Klinikum Traunstein — Traunstein, Germany (Recruiting)
Study contacts
- Study coordinator: Rolf Wachter, Prof. Dr.
- Email: rolf.wachter@medizin.uni-leipzig.de
- Phone: +49 341 97 - 20958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.