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NCT04917653: WB-AF

Portable Measurement Methods Combined With Artificial Intelligence in Detection of Atrial Fibrillation

Status unknown Last updated 22 November 2022
What this trial tests

trial testing Heart rhythm monitoring with wearable device in Atrial Fibrillation in 100 participants. Status unknown.

Timeline
7 June 2021
Primary endpoint
31 December 2023
31 December 2023

Quick facts

Lead sponsorKuopio University Hospital
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment100
Start date7 June 2021
Primary completion31 December 2023
Estimated completion31 December 2023
Sites1 location across Finland

Drugs / interventions tested

Conditions studied

Sponsor

Kuopio University Hospital

Who can join

18 and older, any sex, with Atrial Fibrillation or Heart Rate Fast. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In Western countries, every sixth person in their lifetime and 15,000 people in Finland have a new stroke each year. About every fourth stroke is based on cardiac embolism. Atrial fibrillation (AF) is the most common arrhythmia that increases the risk of thromboembolic complications, such as stroke. It may cause formation of thrombi in the left atrium with ensuing embolization in the cerebral and peripheral circulation. AF is often asymptomatic and paroxysmal. Thus, the diagnosis of AF is often challenging. A new onset AF is usually treated with cardioversion (CV), in which the abnormal rhythm is converted back to sinus rhythm (SR). However, a long-lasting AF (\>48 hours) is associated with risk of stroke. Therefore, the duration of AF needs to be known before a CV can be performed. This study evaluates the ability of novel customer-targeted heart measuring devices to detect rhythm change and short AF episodes. Moreover, novel biomarkers will be analyzed from the blood samples of AF patients and their suitability to estimate the duration of AF will be evaluated. The research will be accomplished in cooperation with the Kuopio University Hospital Emergency Department, the Heart Center, the Department of Applied Physics of the University of Eastern Finland and Heart2Save Ltd. The results of the research project will be published in the scientific journals of medicine and medical technology and will be presented at scientific conferences of the respective fields. The research results of the project can be utilized by all companies in the medical technology industry, in particular companies that produce ECG measuring instruments and companies that produce rhythm recognition software.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Early diagnosis and better rhythm management to improve outcomes in patients with atrial fibrillation: the 8th AFNET/EHRA consensus conference.
    Schnabel RB, Marinelli EA, Arbelo E, Boriani G, et al · · 2023 · cited 131× · PMID 35894842 · DOI 10.1093/europace/euac062
  2. Photoplethysmography in recent-onset atrial fibrillation: automatic detection of rhythm change and burden.
    Rantula OA, Lipponen JA, Halonen J, Jäntti H, et al · · 2025 · cited 1× · PMID 40703141 · DOI 10.1093/ehjdh/ztaf055
  3. A Deep Neural Network for Interpreting Wearable Electrocardiogram Data in Atrial Fibrillation: Prospective Observational Diagnostic Accuracy Study.
    Rantula OA, Lipponen JA, Halonen J, Jäntti H, et al · · 2026 · PMID 42024548 · DOI 10.2196/82475

Verify or expand the search:

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

Other Kuopio University Hospital trials

Trials by the same sponsor.

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Data sources for this page

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