Murmur, HeartEVALTRIMODNCT05162599
Evaluation of Cardiags Trimod for Analysis of Cardiac Activity
A study testing Diagnostic study, experimental evaluative cross-sectional study in people with Murmur, Heart and Rhythm; Abnormal, run by CARDIAGS at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Murmur, Heart, Rhythm; Abnormal
- What is being tested?
- Diagnostic study, experimental evaluative cross-sectional study
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2022to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Persons suitable for receiving an echocardiogram and an electrocardiogram,
- People who signed the consent form,
Who cannot join
- Protected and vulnerable people,
- People refusing to participate in the study,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cardiags Trimod, a New Medical Device for Screening Cardiac Abnormalities
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.
Read the 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.
- Conditions
- Murmur, Heart, Rhythm; Abnormal
- Being tested
- Diagnostic study, experimental evaluative cross-sectional study
- Keywords
- Medical examination device, Connected cardiac auscultation, Sensors, Heartbeat, Heart sounds, Pulse wave, Electrocardiogram, Pathological heart sounds
- Medical subject headings
- Heart Murmurs, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic study, experimental evaluative cross-sectional studyDevice
Also called Noinvasive multisensors cardiac examination
This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference test) and the new device
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic study, experimental evaluative cross-sectional study | Experimental | 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 Receives: Device: Diagnostic study, experimental evaluative cross-sectional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Murmurs detection
Evaluate the performance of Cardiags Trimod compared to a reference examination, echocardiography, for the detection of murmurs: Presence/Absence
Measured: 15 minutes
Heart rhythm disorders
Abnormal and irregular heart rhythm
Measured: 15 minutes
Secondary outcomes (4)
Accuracy of cardiac intervals measures
Measures accuracy
Measured: 15 minutes
Reproductibilty of measurements
Repetition of three measurements by the same operator
Measured: 15 minutes
Security and usability
collection of problems and incidents during clinical study
Measured: 1 year
Acceptability
satisfaction survey
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start8 Jun 2022
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Murmur, HeartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- CARDIAGS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurent Mr Boisson, Dr, Principal investigator, Hopital Fourvière Lyon FranceBernard Mr RITZ, Dr, Principal investigator, Hopital Fourvière Lyon France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162599
- Sponsor's protocol ID
- CDGS-EC-01
- Acronym
- EVALTRIMOD
- Status last verified
- Jun 2023
- First submitted
- 6 Dec 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiags Trimod, a New Medical Device for Screening Cardiac Abnormalities
- ClinicalTrials.gov ID
- NCT05162599
- Acronym / sponsor ID
- EVALTRIMOD / CDGS-EC-01
- Conditions
- Murmur, Heart, Rhythm; Abnormal
- Keywords
- Medical examination device, Connected cardiac auscultation, Sensors, Heartbeat, Heart sounds, Pulse wave, Electrocardiogram, Pathological heart sounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- CARDIAGSIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference tests) and the new device
| Arm | Type | Receives |
|---|---|---|
| Diagnostic study, experimental evaluative cross-sectional study | Experimental | Device: Diagnostic study, experimental evaluative cross-sectional studyEvaluate 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 |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Persons suitable for receiving an echocardiogram and an electrocardiogram,
- People who signed the consent form,
Key exclusion criteria (2 listed)
- Protected and vulnerable people,
- People refusing to participate in the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic study, experimental evaluative cross-sectional studyAlso: Noinvasive multisensors cardiac examinationThis is a cross-sectional diagnostic study with collection of information from the gold standard (or reference test) and the new device | Device | Diagnostic study, experimental evaluative cross-sectional study |
Primary outcome
Murmurs detection
Time frame: 15 minutes
Evaluate the performance of Cardiags Trimod compared to a reference examination, echocardiography, for the detection of murmurs: Presence/Absence
Heart rhythm disorders
Time frame: 15 minutes
Abnormal and irregular heart rhythm
4 secondary outcomes
Accuracy of cardiac intervals measures
Time frame: 15 minutes
Reproductibilty of measurements
Time frame: 15 minutes
Security and usability
Time frame: 1 year
Acceptability
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Murmur, Heart
RecruitingPhase 2
A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
Uncontrolled Hypertension
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
Heart Failure, Heart Failure Preserved Ejection Fraction
RecruitingObservational study
Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
Atrial Fibrillation
Recruiting
EKO SENSORA: Detecting Clinically Significant Murmurs
Heart Murmurs
Enrolling by invitationObservational study
Can Smartphones Listen to Your Heart? A Performance Study on Detecting Inborn Heart Diseases in Your Heart Sounds
Congenital Heart Disease (CHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Mr Boisson, Dr principal investigator
Hopital Fourvière Lyon France
Bernard Mr RITZ, Dr principal investigator
Hopital Fourvière Lyon France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic study, experimental evaluative cross-sectional study in people with Murmur, Heart and Rhythm; Abnormal, run by CARDIAGS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Murmurs detection (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.