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

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ClinicalTrials.gov Identifier: NCT03975725
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cardiovascular Illnesses Device: the use of the WitCard Other: the use of WitDisplayer Not Applicable

Detailed Description:
Monocentric, prospective, interventional study

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of an Ultraportable ECG Recording Device and Its Visualization Software for the Detection of Atrial Fibrillation
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: witcard Device: the use of the WitCard
electrocardiogram (ECG)

Other: 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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 9 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975725


Contacts
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Contact: jean-claude deharo 04 91 69 89 24 JeanClaude.DEHARO@ap-hm.fr

Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: jean-olivier ARNAUD Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03975725     History of Changes
Other Study ID Numbers: 2018-67
2019-A00918-49 ( Other Identifier: idrcb )
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes