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SmartWatch-driven AF Detection in Stroke Patients

NCT06832579 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-29

No results posted yet for this study

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

Interventions

DEVICE

Wearable

semi-continuous heart rhythm monitoring with Wearable

Sponsors & Collaborators

  • University of Leipzig

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06832579 on ClinicalTrials.gov