Back to resultsEvaluation of Cardiags Trimod for Analysis of Cardiac Activity (EVALTRIMOD)
Primary Purpose
Murmur, Heart, Rhythm; Abnormal
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnostic study, experimental evaluative cross-sectional study
Sponsored by
About this trial
This is an interventional diagnostic trial for Murmur, Heart focused on measuring Medical examination device, Connected cardiac auscultation, Sensors, Heartbeat, Heart sounds, Pulse wave, Electrocardiogram, Pathological heart sounds
Eligibility Criteria
Inclusion Criteria:
- Persons suitable for receiving an echocardiogram and an electrocardiogram,
- People who signed the consent form,
Exclusion Criteria:
- Protected and vulnerable people,
- People refusing to participate in the study,
Sites / Locations
- Hôpital de Fourvière
- Hôpital de FourvièreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic study, experimental evaluative cross-sectional study
Arm Description
Evaluate the performance of the Cardiags Trimod medical device, compared to a reference examination, echocardiography, for the detection of heart murmurs Verification of the performance of the Cardiags Trimod medical device compared to a reference examination (ECG, Cardiologist interpretation) for the detection of rythm abnormalities Verification of the repeatability of measurements Verification of safety and suitability for use Verification of acceptability
Outcomes
Primary Outcome Measures
Murmurs detection
Evaluate the performance of Cardiags Trimod compared to a reference examination, echocardiography, for the detection of murmurs: Presence/Absence
Heart rhythm disorders
Abnormal and irregular heart rhythm
Secondary Outcome Measures
Accuracy of cardiac intervals measures
Measures accuracy
Reproductibilty of measurements
Repetition of three measurements by the same operator
Security and usability
collection of problems and incidents during clinical study
Acceptability
satisfaction survey
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05162599
Brief Title
Evaluation of Cardiags Trimod for Analysis of Cardiac Activity
Acronym
EVALTRIMOD
Official Title
Evaluation of Cardiags Trimod, a New Medical Device for Screening Cardiac Abnormalities
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CARDIAGS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The current study concerns Cardiags Trimod, a new non-invasive medical device for cardiac examinations. The evaluation of its effectiveness is done relative to specific standard devices.
Detailed Description
Cardiags Trimod, the subject of this study, is a new medical device for rapid and early detection of some of cardiac abnormalities, easy to use by non-cardiologists and portable wherever the patient is. Cardiags Trimod, consisting of a device and software, allows simultaneous recording, visualization and analysis in real time of signals characteristic of cardiac function. It assists healthcare professionals by measuring characteristic time intervals of cardiac function by crossing the various signals, by detecting abnormal rhythms, and murmurs.
The study aims to assess the essential requirements : the effectiveness and safety of the device. The study is a research involving the human person.Cardiags Trimod is a medical device with low risk. There is no identified risk for the patient.The patient sample tested consists of sick and healthy individuals. The use of Cardiags Trimod is part of the patient's usual consultation. The identified Gold standards are EKG and echocardiography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Murmur, Heart, Rhythm; Abnormal
Keywords
Medical examination device, Connected cardiac auscultation, Sensors, Heartbeat, Heart sounds, Pulse wave, Electrocardiogram, Pathological heart sounds
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference tests) and the new device
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic study, experimental evaluative cross-sectional study
Arm Type
Experimental
Arm Description
Evaluate the performance of the Cardiags Trimod medical device, compared to a reference examination, echocardiography, for the detection of heart murmurs Verification of the performance of the Cardiags Trimod medical device compared to a reference examination (ECG, Cardiologist interpretation) for the detection of rythm abnormalities Verification of the repeatability of measurements Verification of safety and suitability for use Verification of acceptability
Intervention Type
Device
Intervention Name(s)
Diagnostic study, experimental evaluative cross-sectional study
Other Intervention Name(s)
Noinvasive multisensors cardiac examination
Intervention Description
This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference test) and the new device
Primary Outcome Measure Information:
Title
Murmurs detection
Description
Evaluate the performance of Cardiags Trimod compared to a reference examination, echocardiography, for the detection of murmurs: Presence/Absence
Time Frame
15 minutes
Title
Heart rhythm disorders
Description
Abnormal and irregular heart rhythm
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Accuracy of cardiac intervals measures
Description
Measures accuracy
Time Frame
15 minutes
Title
Reproductibilty of measurements
Description
Repetition of three measurements by the same operator
Time Frame
15 minutes
Title
Security and usability
Description
collection of problems and incidents during clinical study
Time Frame
1 year
Title
Acceptability
Description
satisfaction survey
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Persons suitable for receiving an echocardiogram and an electrocardiogram,
People who signed the consent form,
Exclusion Criteria:
Protected and vulnerable people,
People refusing to participate in the study,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nacira MS ZEGADI, Dr Ing
Phone
+33630615355931
Email
nzegadi@cardiags.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie MS RIBAULT, Dr
Phone
+33472573321
Email
lucie.ribault@hopital-fourviere.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Mr Boisson, Dr
Organizational Affiliation
Hopital Fourvière Lyon France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernard Mr RITZ, Dr
Organizational Affiliation
Hopital Fourvière Lyon France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de Fourvière
City
Lyon
ZIP/Postal Code
69005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie MS RIBAULT, DR
Phone
+33472573321
Email
lucie.ribault@hopital-fourviere.fr
First Name & Middle Initial & Last Name & Degree
Bernard MR RITZ, DR
Phone
0472573034
Email
bernard.ritz2@hopital-fourvière.fr
First Name & Middle Initial & Last Name & Degree
Laurent MR Boisson, DR
Facility Name
Hôpital de Fourvière
City
Lyon
ZIP/Postal Code
69005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hôpital de Fourvière
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Cardiags Trimod for Analysis of Cardiac Activity
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