RecruitingNot ApplicableNCT06005233

Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke

Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke - WATCH AFib A Prospective, Intraindividual-controlled, Multicenter Clinical Study


Sponsor

Technical University of Munich

Enrollment

400 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Scientific Background: In secondary prevention of ischemic stroke, detection of atrial fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of recurrent stroke by approximately 60%. Prolonged electrocardiogram (ECG) monitoring up to 6 months significantly increases detection of AFib in cryptogenic stroke. Wearables like smartwatches have recently been shown to adequately detect AFib in the general population. Thus, prolonged ECG monitoring after cryptogenic ischemic stroke or transient ischemic attack (TIA) using a smartwatch could lead to a reduction of recurrent stroke by prompting adequate anticoagulation therapy and may constitute a cost-effective, non-invasive, and broadly-available alternative to the current standard of care. Hypothesis: The investigators hypothesize that AFib detection via smartwatch in patients with cryptogenic TIA or ischemic stroke is accurate compared to an implantable event recorder. Methods: The investigators introduce a prospective, intraindividual-controlled, multicentre clinical study in patients with cryptogenic ischemic stroke or TIA. In addition to an implanted event recorder as indicated by clinical standard, included patients receive a smartwatch for detection of AFib. ECG-data from smartwatches will be continuously monitored by two independent cardiologists. As soon as AFib is confirmed, a doctoral appointment is set to evaluate start of anticoagulation. The follow-up period will be six months. The study consists of four study visits: a baseline visit, two phone visits at one and three months, and an end of trial visit at six months. Primary Objective: To compare smartwatch and event recorder based analysis for sensitivity and specificity of AFib detection per patient after six months


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a smartwatch to detect irregular heart rhythms (atrial fibrillation or AFib) can help prevent another stroke in people who had a stroke of unknown cause (called cryptogenic stroke). **You may be eligible if:** - You are 40 or older - You already have an implanted heart monitor (event recorder with telemedicine function) - You had a cryptogenic stroke or a certain type of mini-stroke (TIA) within the past 6 months - You have at least one risk factor for AFib (such as a high stroke risk score, enlarged left atrium, or runs of fast heart beats) - You are eligible for blood thinner therapy **You may NOT be eligible if:** - You cannot use a smartwatch to record a 1-lead ECG - You do not own a smartphone - You have a pacemaker or implanted defibrillator - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESmartwatch

Smartwatch with PPG- and 1-lead ECG derived analysis of cardiac arrhythmia. Analysis will be performed centrally at the Cardiology Core Lab at the Klinikum Rechts der Isar.


Locations(1)

Klinikum rechts der Isar, Technische Universität München

Munich, Germany

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NCT06005233


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