SmartWatch-driven AF Detection in Stroke Patients (Find-AF2 Watch)

April 28, 2026 updated by: Rolf Wachter, University of Leipzig

Pilot Study for SmartWatch-driven AF Detection in Stroke Patients

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 University Hospital since 2020 with the help of about 50 study centers throughout Germany.

The AppleWatch Series 10, a device from the current market leader, was chosen because extensive data from clinical trials is already available and data regarding the market leader has particular societal relevance. The AF detection algorithm is based on photoplethysmography (analysis of the pulse current curve) and semicontinuous monitoring. If a rhythm irregularity is detected during hourly measurements, the measurement interval is shortened. If this finding is confirmed in several consecutive measurements, the user is notified. In this pilot study, patients are trained to record a 30-second ECG with the AppleWatch in the event of notification. This is done by placing the other hand on the crown of the watch. The report will then be transmitted. The AppleWatch must be paired with another Apple device (e.g. iPhone) to use the ECG app and must be charged daily (battery life 18 hours). Our patients are provided with an iPhone for study use and are trained in using the AppleWatch.

The AppleWatch is not certified as medical device, but the ECG data collected by the AppleWatch will be used for research purposes only and not for therapeutical or diagnostical purposes.

The second wearable will be the PulseOn device. The battery lasts over two weeks. No additional device is needed for writing an ECG. AF screening is also performed photoplethysmographically. In the case of detection of an arrhythmic pulse curve, this is communicated by vibration. By laying the other hand on the device, a 1-channel ECG is performed for registration. Regular data transfer is done at the patient's home via a gateway device to the PulseOn server. The Core lab will monitor the data transmission. Although PulseOn is a certified medical device, the ECG data collected by the PulseOn device will be used for research purposes only and not for therapeutical or diagnostical purposes. The ICM is the gold standard for recording relevant arrhythmias.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Neustadt an der Saale, Germany, 97616
        • RHÖN-KLINIKUM Campus Bad Neustadt Von-Guttenberg-Straße 11 Akutneurologie II - Stroke Unit - klinische Forschung
      • Bielefeld, Germany, 33611
        • Evangelisches Klinikum Bethel, Clinic for Neurology
      • Dresden, Germany
        • Medizinische Fakultät Carl Gustav Carus Klinik und Poliklinik für Neurologie
      • Erlangen, Germany, 91054
        • Universitätklinikum Erlangen Neurologische Klinik, Schwabachanlage 6
      • Essen, Germany, 45147
        • University of Essen, Clinic of Neurology
      • Göttingen, Germany, 37075
        • University of Göttingen, Clinic for Neurology
      • Halle, Germany, 06120
        • Krankenhaus Martha-Maria Halle-Dölau
      • Ibbenbueren, Germany, 49477
        • Klinik für Neurologie Klinikum Ibbenbüren Große Str. 41
      • Leipzig, Germany, 04103
        • University Hospital Leipzig, Clinic for Neurology
      • Mainz, Germany, 55131
        • University of Mainz, Clinic for Neurology
      • Minden, Germany, 32429
        • Johannes Wesling Klinikum Minden Universitätsklinik für Neurologie und Neurogeriatrie Hans-Nolte-Str. 1
      • Nuremberg, Germany, 90471
        • Klinik für Neurologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Breslauer Str. 201
      • Traunstein, Germany, 83278
        • Kliniken Südostbayern AG, Klinikum Traunstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AppleWatch

semi-continuous heart rhythm monitoring with AppleWatch

for 12 weeks
Device: Wearable
semi-continuous heart rhythm monitoring with Wearable
Experimental: PulseOn

semi-continuous heart rhythm monitoring with PulseOn device

for 12 weeks
Device: Wearable
semi-continuous heart rhythm monitoring with Wearable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity as a function of AF duration
Time Frame: from the date of device handover to the date of device return
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time worn
Time Frame: from the date of device handover to the date of device return
the proportion of time that the wearable collected and transferred data
from the date of device handover to the date of device return
Detection sensitivity as a function of AF duration
Time Frame: from the date of device handover to the date of device return
If the device is being worn during at least 120 seconds of an AF episode, what is the probability of its informing the patient of an arrhythmia?
from the date of device handover to the date of device return
ECG compliance
Time Frame: from the date of device handover to the date of device return
if the wearable informs of an episode, what is the probability that the patient will let the device save an ECG
from the date of device handover to the date of device return
Overall sensitivity
Time Frame: from the date of device handover to the date of device return
For patients who had at least one AF episode, what is the probability that the wearable claims there was at least one episode?
from the date of device handover to the date of device return
Time to first ECG-confirmed AF episode
Time Frame: from the date of device handover to the date of device return
from the date of device handover to the date of device return
Overall specificity
Time Frame: from the date of device handover to the date of device return
for patients who had no AF episodes, what is the probability that there is no ECG confirmation of any episodes?
from the date of device handover to the date of device return
False discovery rate (1-PPV (positive predictive value)
Time Frame: from the date of device handover to the date of device return
For every ECG-confirmed episode found by the wearable, the gold standard episode definition will be used for comparison
from the date of device handover to the date of device return
For the ICM: What proportion of detected signals are available as ECGs?
Time Frame: from the date of device handover to the date of device return
from the date of device handover to the date of device return
For the ICM: What is the false discovery rate of the available ECGs?
Time Frame: from the date of device handover to the date of device return
from the date of device handover to the date of device return
Do patients with an ICM claim to be willing to be randomized to an ICM vs a wearable?
Time Frame: after 12 weeks
after 12 weeks
Patient satisfaction with the wearable
Time Frame: after 12 weeks
after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Find-AF2 Watch

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

after publication of the major results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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