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Smartwatches vs. implants: a new way to catch Stroke-Causing irregular heartbeats?

NCT ID NCT06832579

Diagnosis Sponsor: University of Leipzig Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tests whether smartwatches can detect atrial fibrillation (AF) in people who recently had a stroke. Participants already have an implanted heart monitor (the gold standard) and will also wear a smartwatch for 12 weeks. The goal is to see how well the smartwatch catches AF episodes compared to the implant, which could lead to easier and cheaper monitoring for stroke survivors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Smartwatch (Apple Watch or PulseOn) for heart rhythm monitoring
What this could lead to
If successful, smartwatches could offer a non-invasive, low-cost way to detect hidden atrial fibrillation after a stroke, potentially preventing future strokes.
What could go wrong
This is a small pilot study (84 people) testing sensitivity, not treatment. Smartwatches may miss short AF episodes or have lower accuracy than implanted monitors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

84 people

The number who actually took part.

Started

May 2025

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation ischemic stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF) Ecg monitoring Ischemic stroke Secondary prevention Wearables

Contacts and locations

Locations

  • Evangelisches Klinikum Bethel, Clinic for Neurology

    Bielefeld, 33611, Germany

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

    Minden, 32429, Germany

  • Klinik für Neurologie Klinikum Ibbenbüren Große Str. 41

    Ibbenbueren, 49477, Germany

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

    Nuremberg, 90471, Germany

  • Kliniken Südostbayern AG, Klinikum Traunstein

    Traunstein, 83278, Germany

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle, 06120, Germany

  • Medizinische Fakultät Carl Gustav Carus Klinik und Poliklinik für Neurologie

    Dresden, Germany

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

    Bad Neustadt an der Saale, 97616, Germany

  • University Hospital Leipzig, Clinic for Neurology

    Leipzig, 04103, Germany

  • University of Essen, Clinic of Neurology

    Essen, 45147, Germany

  • University of Göttingen, Clinic for Neurology

    Göttingen, 37075, Germany

  • University of Mainz, Clinic for Neurology

    Mainz, 55131, Germany

  • Universitätklinikum Erlangen Neurologische Klinik, Schwabachanlage 6

    Erlangen, 91054, Germany

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