Health ScreeningNCT05364541
MyoVista wavECG Clinical Evaluation: >=60 y/o Enrichment Population
A study testing MyoVista wavECG in people with Health Screening, run by Heart Test Laboratories, Inc. at 1 site in United States.
Trial summary
This is a single-center, interventional, single arm clinical study of the MyoVista wavECG for the detection of LV relaxation abnormalities. The study will be conducted at a single investigational site within the United States. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Screening
- What is being tested?
- MyoVista wavECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 30 Nov 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is >=60 years of age
- Subjects will predominately be recruited among those who are already enrolled in existing registry studies within the institution.
- The subject provides written informed consent using an Informed Consent Form that is reviewed and approved by the site's Institutional Review Board (IRB).
- Conventional ECG results show a sinus rhythm and no other contraindicated rhythm abnormalities (see exclusions below).
Who cannot join
- The subject has current acute coronary syndrome, decompensated heart failure or stroke
- The subject has received any prior cardiac interventions or surgical therapeutic procedures relating to cardiac abnormalities: valve replacement, pacemaker implantation, coronary artery bypass grafting (CABG), heart transplant, ablation, coronary stent placement, etc.
- Conventional ECG results indicating a lack of sinus rhythm and/or any other contraindicated rhythm abnormalities, including: active atrial fibrillation or atrial flutter, left anterior fascicular block, left and/or right bundle branch block
- The subject is pregnant at the time of the study testing
- The subject has chest deformities that interfere with accurate measurement of ECG (either conventional or wavECG)
- Subjects with central nervous system or musculoskeletal abnormalities that may interfere with accurate acquisition of ECG and/or echocardiogram measurements.
- The subject is enrolled in another clinical study that may interfere with MyoVista or echocardiogram measurements. Exceptions to this may be approved by HeartSciences.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Center
Dallas, Texas, 75390
About this study
This is a single-center, interventional, single arm clinical study of the MyoVista wavECG for the detection of LV relaxation abnormalities. The study will be conducted at a single investigational site within the United States. Study subjects will predominately be screened from among those who have been enrolled in prior registry studies by the institution.
Read the detailed description
The study has a planned enrollment of at least 50 subjects to obtain approximately 40 subjects with a "normal" septal and lateral e' value on echocardiogram. The criteria defined as septal e'< 7 cm/s or lateral e'< 10 cm/s for relaxation abnormality based on ASE/AECVI guidelines will be used for the evaluation of LV diastolic function which is associated with abnormal relaxation in echocardiography. An independent Core Lab will verify all septal and lateral e' values on the site-acquired echocardiograms and these Core Lab measurements will serve as the ground truth standard with regard to the presence of LV relaxation abnormalities.
Analysis of data from a prior multi-center study has revealed good correlation between the MyoVista wavECG results and echocardiography for the presence of LV relaxation abnormalities. This current study (HS-CLINVAL-002) is intended to supplement data collected in prior and ongoing studies, namely HS-CLINVAL-001, by recruiting individuals who are >60 years old and who are anticipated to have normal echocardiogram results based on a screening of selected clinical characteristics. Subjects in this study will be invited to participate and receive non-standard-of-care echocardiograms and a study driven MyoVista test.
The study will continue to focus on LV relaxation abnormalities by gathering additional device validation data for the purposes of regulatory approval peer-reviewed publications. Echocardiograms of study subjects will be used to compare/validate the study findings.
- Conditions
- Health Screening
- Being tested
- MyoVista wavECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoVista wavECGDevice
A standard 12-Lead, multi-channel resting interpretive trans-thoracic electrocardiograph providing both a Glasgow Interpretive Analysis and unique MyoVista wavECG Information for the detection of Left Ventricular Diastolic Dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| MyoVista wavECG | Other | Single arm - subjects meeting the inclusion, exclusion and screening criteria will receive a MyoVista wavECG and a trans-thoracic echocardiogram. Receives: Device: MyoVista wavECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance
Sensitivity and specificity of the MyoVista for the classification of Low e' where a "positive" includes a MyoVista wavECG result of Positive and Highly Positive. The study result will be considered to have achieved the pre-specified performance criteria for success if the sensitivity is demonstrated to exceed 70% and the specificity is demonstrated to exceed 70%.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start1 Jun 2022
- Primary completion15 Jul 2023
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health ScreeningStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Test Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Partho Sengupta, MD, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364541
- Sponsor's protocol ID
- HS-CLINVAL-002
- Status last verified
- Feb 2023
- First submitted
- 28 Apr 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyoVista wavECG Clinical Evaluation: >=60 y/o Enrichment Population
- ClinicalTrials.gov ID
- NCT05364541
- Acronym / sponsor ID
- HS-CLINVAL-002
- Conditions
- Health Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Heart Test Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 6 May 2022 (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.
This is a single-center, interventional, single arm clinical study of the MyoVista wavECG for the detection of LV relaxation abnormalities. The study will be conducted at a single investigational site within the United States. Study subjects will predominately be screened from among those who have been enrolled in prior registry studies by the institution.
Detailed description
The study has a planned enrollment of at least 50 subjects to obtain approximately 40 subjects with a "normal" septal and lateral e' value on echocardiogram. The criteria defined as septal e'< 7 cm/s or lateral e'< 10 cm/s for relaxation abnormality based on ASE/AECVI guidelines will be used for the evaluation of LV diastolic function which is associated with abnormal relaxation in echocardiography. An independent Core Lab will verify all septal and lateral e' values on the site-acquired echocardiograms and these Core Lab measurements will serve as the ground truth standard with regard to the presence of LV relaxation abnormalities.
Analysis of data from a prior multi-center study has revealed good correlation between the MyoVista wavECG results and echocardiography for the presence of LV relaxation abnormalities. This current study (HS-CLINVAL-002) is intended to supplement data collected in prior and ongoing studies, namely HS-CLINVAL-001, by recruiting individuals who are >60 years old and who are anticipated to have normal echocardiogram results based on a screening of selected clinical characteristics. Subjects in this study will be invited to participate and receive non-standard-of-care echocardiograms and a study driven MyoVista test.
The study will continue to focus on LV relaxation abnormalities by gathering additional device validation data for the purposes of regulatory approval peer-reviewed publications. Echocardiograms of study subjects will be used to compare/validate the study findings.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyoVista wavECG | Other | Device: MyoVista wavECGSingle arm - subjects meeting the inclusion, exclusion and screening criteria will receive a MyoVista wavECG and a trans-thoracic echocardiogram. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is >=60 years of age
- Subjects will predominately be recruited among those who are already enrolled in existing registry studies within the institution.
- The subject provides written informed consent using an Informed Consent Form that is reviewed and approved by the site's Institutional Review Board (IRB).
- Conventional ECG results show a sinus rhythm and no other contraindicated rhythm abnormalities (see exclusions below).
Key exclusion criteria (7 listed)
- The subject has current acute coronary syndrome, decompensated heart failure or stroke
- The subject has received any prior cardiac interventions or surgical therapeutic procedures relating to cardiac abnormalities: valve replacement, pacemaker implantation, coronary artery bypass grafting (CABG), heart transplant, ablation, coronary stent placement, etc.
- Conventional ECG results indicating a lack of sinus rhythm and/or any other contraindicated rhythm abnormalities, including: active atrial fibrillation or atrial flutter, left anterior fascicular block, left and/or right bundle branch block
- The subject is pregnant at the time of the study testing
- The subject has chest deformities that interfere with accurate measurement of ECG (either conventional or wavECG)
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 |
|---|---|---|
| MyoVista wavECGA standard 12-Lead, multi-channel resting interpretive trans-thoracic electrocardiograph providing both a Glasgow Interpretive Analysis and unique MyoVista wavECG Information for the detection of Left Ventricular Diastolic Dysfunction. | Device | MyoVista wavECG |
Primary outcome
Diagnostic Performance
Time frame: Baseline
Sensitivity and specificity of the MyoVista for the classification of Low e' where a "positive" includes a MyoVista wavECG result of Positive and Highly Positive. The study result will be considered to have achieved the pre-specified performance criteria for success if the sensitivity is demonstrated to exceed 70% and the specificity is demonstrated to exceed 70%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Partho Sengupta, MD principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoVista wavECG in people with Health Screening, run by Heart Test Laboratories, Inc. at 1 site in United States.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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 United States. 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?
Results are not available in the source record.
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?
Diagnostic Performance (time frame: Baseline). 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 21 Sep 2023.