Hôpital Haut-Lévèque
Pessac, 33604, France
Location status: Recruiting
Location contact
Pierre BORDACHAR
CONTACT
Recruiting
NCT Number: NCT06272396
Relevance of Recording an ECG Trace With a Connected Watch
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 heart's rhythm. The information that can be derived from an ECG recording with a derivation goes far beyond̀ 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients hospitalized or seen in consultation in one of the departments of the Haut Lévêque cardiology hospital,
- Patient of both sexes, minor (from birth to 18 years) or adult,
- Free, informed and written consent from the patient or, in the case of minors, from the legal parent (at the latest on the day of inclusion and before any examination required for the research),
- Subject affiliated to or benefiting from a social security regime.
Exclusion criteria
- Person incapable of giving consent,
- Person subject to a legal protection measure (safeguard of justice, tutorship or curatorship),
- A person deprived of liberty by judicial or administrative decision.
Treatment and study plan
Smart watch
DeviceECG 1D/6D
Primary outcomes
-
Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude
Time frame: 36 months
Mean of P-wave amplitude
-
Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration
Time frame: 36 months
Mean of P-wave duration
-
Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude
Time frame: 36 months
Mean of QRS amplitude
-
Comparison of electrical parameters measured using the 2 ECG methods: QRS duration
Time frame: 36 months
Mean of QRS duration
-
Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc
Time frame: 36 months
Mean of QT/QTc (corrected QT) intervals
Secondary outcomes
-
Creation of bank of anormal ECG trace
Time frame: 36 months
Number of ECG-1D/6D and 12 derivations
-
Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG
Time frame: 36 months
Accuracy of diagnostic
-
Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home
Time frame: 36 months
Number of ECG-1D/6D and 12 derivations
-
Validate the feasibility of recording an ECG trace with a connected watch for a child
Time frame: 36 months
Number of ECG-1D/6D and 12 derivations
-
Validate the sensibility of an ECG trace with a connected watch for a child
Time frame: 36 months
Quality of ECG-1D/6D
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospital, Bordeaux
Other
Registry information
Official study title
Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch
Acronym: ECG-MC
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Feb 22, 2024
- Registry last updated
- Apr 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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