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出境医 / 临床实验 / Evaluation of an Ultraportable ECG Recording Device and Its Visualization Software for the Detection of Atrial Fibrillation (WITCARD)

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

Study Description
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
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
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
Arms and Interventions
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.
Outcome Measures
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 ]

Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: jean-claude deharo 04 91 69 89 24 JeanClaude.DEHARO@ap-hm.fr

Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Layout table for investigator information
Study Director: jean-olivier ARNAUD Assistance Publique Hopitaux De Marseille
Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date June 5, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019) 		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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of an Ultraportable ECG Recording Device and Its Visualization Software for the Detection of Atrial Fibrillation
Official Title  ICMJE Evaluation of an Ultraportable ECG Recording Device and Its Visualization Software for the Detection of Atrial Fibrillation
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cardiovascular Illnesses
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: witcard
Interventions:
  • Device: the use of the WitCard
  • Other: the use of WitDisplayer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019) 		400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: jean-claude deharo 04 91 69 89 24 JeanClaude.DEHARO@ap-hm.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975725
Other Study ID Numbers  ICMJE 2018-67
2019-A00918-49 ( Other Identifier: idrcb )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: jean-olivier ARNAUD Assistance Publique Hopitaux De Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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