Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart watch | Experimental | ECG done with smart watch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart watch | Device | ECG 1D/6D |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude | Mean of P-wave amplitude | 36 months |
| Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration | Mean of P-wave duration | 36 months |
| Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude | Mean of QRS amplitude | 36 months |
| Comparison of electrical parameters measured using the 2 ECG methods: QRS duration | Mean of QRS duration | 36 months |
| Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc | Mean of QT/QTc (corrected QT) intervals | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Creation of bank of anormal ECG trace | Number of ECG-1D/6D and 12 derivations | 36 months |
| Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre BORDACHAR | Contact | +335 57 65 64 71 | pierre.bordachar@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre BORDACHAR | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Haut-Lévèque | Recruiting | Pessac | 33604 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Accuracy of diagnostic
| 36 months |
| Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home | Number of ECG-1D/6D and 12 derivations | 36 months |
| Validate the feasibility of recording an ECG trace with a connected watch for a child | Number of ECG-1D/6D and 12 derivations | 36 months |
| Validate the sensibility of an ECG trace with a connected watch for a child | Quality of ECG-1D/6D | 36 months |