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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00918-49 | Other Identifier | idrcb |
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The purpose is to demonstrate the usefulness of WitCard and WitDisplayer in the diagnosis of AF but more generally in the qualification of the heart rhythm and the diagnosis of cardiac arrhythmias.
The main objective is therefore to demonstrate that at least 90 +/- 0.03% of ECGWs are interpretable by a physician and the primary endpoint will therefore be the ratio of the number of ECGWs that allowed a physician to make a diagnosis. rhythmic (ECGW interpretable) and the total number of ECGW recorded and viewed.
The clinical trial as part of the CE medical device certification process for secondary objectives and ancillary studies will be required to assess the diagnostic performance of the WitCard + WitDisplayer system, the quality of the ECGW recorded by the WitCard, the the safety of using the WitCard, the technical performance of the WitCard ECG recorder, the ergonomics of the WitCard, and finally the performance of automatic cardiac rhythm classification algorithms.
Monocentric, prospective, interventional study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| witcard | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the use of the WitCard | Device | electrocardiogram (ECG) |
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| the use of WitDisplayer |
| Measure | Description | Time Frame |
|---|---|---|
| the ratio between the number of ECGWs that allowed a physician to make a rhythmic diagnosis (ECGW interpretable) and the total number of ECGWs recorded and visualized. | 9 months |
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Inclusion Criteria:
Patient, male or female, over 18 years of age, presenting to the cardiology-rhythmology department (consultations and hospitalizations) or to the emergency department of the Timone 2 Hospital for the management of suspicion of disorder heart rate in front of:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jean-claude deharo | Contact | 04 91 69 89 24 | JeanClaude.DEHARO@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| jean-olivier ARNAUD | Assistance Publique Hopitaux De Marseille | Study Director |
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| Other |
a software to visualize, measure, annotate, comment, archive, and share the different ECGs acquired with the WitCard (ECGW) of different patients. |
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