Evaluation of an Ultraportable ECG Recording Device and Its Visualization Software for the Detection of Atrial Fibrillation (WITCARD)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: Cardiovascular Illnesses

Treatments: Other: the use of WitDisplayer; Device: the use of the WitCard

Study type: Interventional

Funder types: Other

Identifiers

NCT03975725

2019-A00918-49 (Other Identifier)

2018-67

Details and patient eligibility

About

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.

Full description

Monocentric, prospective, interventional study

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

witcard

Experimental group

Treatment:

Other: the use of WitDisplayer

Device: the use of the WitCard