Relevance of Recording an ECG Trace With a Connected Watch
NCT06272396 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000
Last updated 2025-04-02
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 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.
Conditions
- Arrhythmias, Cardiac
Interventions
- DEVICE
-
Smart watch
ECG 1D/6D
Sponsors & Collaborators
-
University Hospital, Bordeaux
lead OTHER
Principal Investigators
-
Pierre BORDACHAR · University Hospital, Bordeaux
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-26
- Primary Completion
- 2027-03-26
- Completion
- 2028-03-26
Countries
- France
Study Locations
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