Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT07148934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validity and Algorithm Development for Detection of Supraventricular Tachycardia in Children-A Clinical Pilot Study
Sponsor:
University of Turku
Organization:
Study Overview
Official Title:
Validity and Algorithm Development for Detection of Supraventricular Tachycardia in Children-A Clinical Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: