Cardiovascular Illnesses Clinical Trial
— WITCARDOfficial title:
Evaluation of an Ultraportable ECG Recording Device and Its Visualization Software for the Detection of Atrial Fibrillation
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.
| Status | Not yet recruiting |
| Enrollment | 400 |
| Est. completion date | March 2023 |
| Est. primary completion date | September 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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: - Palpitations - Dyspnoea, acute pulmonary edema, non-ischemic heart failure - Malaise, lipothymia, syncope Exclusion Criteria: - Patients with clinical criteria that do not warrant the use of WitCard: - Immediate vital risk whatever its nature - Rhythmic urgency requiring treatment without delay: respiratory, circulatory or neurological distress - Acute Coronary Syndrome - Pregnant women - Non-beneficiaries of a social security scheme - Persons deprived of their liberty - Patient participating in another study - Patient in a period of exclusion determined by a previous study - Patient under the protection of justice, under guardianship or under guardianship |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |