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

Not Applicable

• Conditions: Cardiovascular Illnesses
• Interventions: Device: the use of the WitCard; Other: the use of WitDisplayer

• Registration Number: NCT03975725
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Monocentric, prospective, interventional study

Study Timeline

• Study First Submitted: 2019-05-28
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-03
• Last Update Submitted: 2019-06-03
• Study First Posted: 2019-06-05
• Last Update Posted: 2019-06-05
• Study Start: 2019-09
• Primary Completion: 2022-09
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
witcard	the use of WitDisplayer	-
witcard	the use of the WitCard	-

Primary Outcome Measures

Name	Time	Method
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