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

NCT ID: NCT03975725

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2023-03-31

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

Conditions

Cardiovascular Illnesses

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

witcard

Group Type: EXPERIMENTAL

the use of the WitCard

Intervention Type: DEVICE

electrocardiogram (ECG)

the use of WitDisplayer

Intervention Type: OTHER

a software to visualize, measure, annotate, comment, archive, and share the different ECGs acquired with the WitCard (ECGW) of different patients.

Interventions

the use of the WitCard

electrocardiogram (ECG)

Intervention Type: DEVICE

the use of WitDisplayer

a software to visualize, measure, annotate, comment, archive, and share the different ECGs acquired with the WitCard (ECGW) of different patients.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jean-olivier ARNAUD

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Central Contacts

jean-claude deharo

Role: CONTACT

JeanClaude.DEHARO@ap-hm.fr

04 91 69 89 24

Other Identifiers

2019-A00918-49

Identifier Type: OTHER

Identifier Source: secondary_id

2018-67

Identifier Type: -

Identifier Source: org_study_id