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Not yet recruiting NCT07148934

Validity and Algorithm Development for Detection of Supraventricular Tachycardia in Children-A Clinical Pilot Study

Observational Supraventricular Tachycardia Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smartphone seismographic recording and Bed Based Ballistocardiographic recordings.
Who it may be relevant to
Registry conditions: Supraventricular Tachycardia, Atrial Fibrillation (AF). Basic parameters: 0 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The aim of this study is to evaluate the reliability of smartphone seismocardiography (SCG) and bed-based ballistocardiography (BCG) for detecting supraventricular tachycardia (SVT) in children aged 0-10 years. The performance of these methods will be compared to the gold standard of continuous telemetry ECG recording.

Detailed description

This study aims to validate the use of a cardiac monitoring system, comprising a smartphone for seismocardiography (SCG) and a smart mattress for ballistocardiography (BCG), to detect supraventricular tachycardia (SVT) in children aged 0-10 years. Additionally, the study will compare heart rate and breathing rate measurements from these investigational devices against a Philips Intellivue X2 ECG Monitor, which serves as the gold standard. A convenience sample of up to 60 children (30 in the SVT group and 30 in the control group) will be recruited, and their parents will also be interviewed to explore their perceptions of arrhythmia monitoring. The primary objective is to develop and understand algorithms for differentiating SVT from sinus rhythm using SCG and BCG signals.

Interventions

  • Diagnostic test Smartphone seismographic recording and Bed Based Ballistocardiographic recordings
    A short recording of heart rhythm using a smartphone and bed-based ballistocardiogram.

Primary outcome measures

  • Algorithm development for Seismocardiograph and Ballistocardiograph for detecting Supraventricular tachycardia [Time frame: 2025-2027]

Eligibility criteria

Inclusion criteria

  • For children in Study(SVT) group:
  • received informed consent from both parents/guardians
  • the child is treated in the Pediatric wards of Tyks Lighthouse hospital
  • the child is between the age of 0-10 years
  • the child has diagnosed or suspected SVT.
  • For children in control group:
  • received informed consent from both parents/guardians
  • the child is treated in the Pediatric wards of Tyks Lighthouse hospital
  • the child is between the age of 0-10 years
  • child has not diagnosed with SVT

Exclusion criteria

  • All participant groups:
  • not reaching the inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Finland · 1 center
  • University of Turku — Turku

Identifiers

NCT: NCT07148934 · FIMEA/2025/002511-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗