Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272396
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-02-15
Brief Title:
Relevance of Recording an ECG Trace With a Connected Watch
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch
Status:
RECRUITING
Status Verified Date:
2024-02
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:
ECG-MC
Brief Summary:
Over the past few years various systems have been developed to record ECG traces on an ambulatory basis The latest connected watch models feature 2-electrode ECG recording This single 1D or six derivations 6D can be used to derive a wealth of information about the hearts rhythm The information that can be derived from an ECG recording with a derivation goes far beyond simple differentiation between atrial fibrillation and sinus rhythm In contrast in various clinical situations a tracing restricted to an intracardiac defibrillator ICD may prove falsely normal wrongly reassuring a patient and delaying management The primary objective of the study is to evaluate the sensitivity of ECG-1D or 6D recordings from a connected watch in measuring electrical parameters compared with a standard ECG-12D also to obtain a bank of tracings to create and validate an artificial intelligence algorithm for the automatic analysis of ECG tracings recorded with a connected watch and also to validate the feasibility and sensitivity of recording an ECG tracing with a connected watch in children
Detailed Description:
Single-arm prospective study to evaluate the measurement of electrocardiographic parameters obtained using two non-invasive ECG methods one 12-lead reference method and the second 1 or 6 leads recorded from a connected watch in a group of patients with healthy hearts normal ECG and 19 pathological groups
Study Oversight
Has Oversight DMC:
None
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?:
None