SmartWatch-driven AF Detection in Stroke Patients

NCT06832579 | Active Not Recruiting

• 1 other identifier: Find-AF2 Watch
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 13

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 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.

Conditions

Atrial Fibrillation (AF); Ischemic Stroke; ECG Monitoring; Secondary Prevention; Wearables

Keywords

ECG monitoring; ICM; Wearables; Stroke; ischemic stroke; atrial fibrillation; secondary prevention

Outcome Measures

Primary Outcomes (1)

• sensitivity as a function of AF duration

  the probability that an AF episode will be detected as it depends on the duration of the episode

  from the date of device handover to the date of device return

Secondary Outcomes (11)

• Time worn

  from the date of device handover to the date of device return

• Detection sensitivity as a function of AF duration

  from the date of device handover to the date of device return

• ECG compliance

  from the date of device handover to the date of device return

• Overall sensitivity

  from the date of device handover to the date of device return

• Time to first ECG-confirmed AF episode

  from the date of device handover to the date of device return

Study Arms (2)

AppleWatch

EXPERIMENTAL

semi-continuous heart rhythm monitoring with AppleWatch for 12 weeks

Device: Wearable

PulseOn

EXPERIMENTAL

semi-continuous heart rhythm monitoring with PulseOn device for 12 weeks

Device: Wearable

Interventions

Wearable DEVICE

semi-continuous heart rhythm monitoring with Wearable

AppleWatch; PulseOn

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (13)

RHÖN-KLINIKUM Campus Bad Neustadt Von-Guttenberg-Straße 11 Akutneurologie II - Stroke Unit - klinische Forschung

Bad Neustadt an der Saale, 97616, Germany

Location

Evangelisches Klinikum Bethel, Clinic for Neurology

Bielefeld, 33611, Germany

Location

Medizinische Fakultät Carl Gustav Carus Klinik und Poliklinik für Neurologie

Dresden, Germany

Location

Universitätklinikum Erlangen Neurologische Klinik, Schwabachanlage 6

Erlangen, 91054, Germany

Location

University of Essen, Clinic of Neurology

Essen, 45147, Germany

Location

University of Göttingen, Clinic for Neurology

Göttingen, 37075, Germany

Location

Krankenhaus Martha-Maria Halle-Dölau

Halle, 06120, Germany

Location

Klinik für Neurologie Klinikum Ibbenbüren Große Str. 41

Ibbenbueren, 49477, Germany

Location

University Hospital Leipzig, Clinic for Neurology

Leipzig, 04103, Germany

Location

University of Mainz, Clinic for Neurology

Mainz, 55131, Germany

Location

Johannes Wesling Klinikum Minden Universitätsklinik für Neurologie und Neurogeriatrie Hans-Nolte-Str. 1

Minden, 32429, Germany

Location

Klinik für Neurologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Breslauer Str. 201

Nuremberg, 90471, Germany

Location

Kliniken Südostbayern AG, Klinikum Traunstein

Traunstein, 83278, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke; Stroke

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Randomised, parallel, multicenter interventional trial

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after publication of the major results

Locations

DE (13)