Hypertrophic CardiomyopathyNCT06600256
Viz HCM (ECG Assist) Utilization Workflow Pilot
An observational study of Hypertrophic Cardiomyopathy, run by Viz.ai, Inc. at 5 sites in United States.
Trial summary
This is a prospective, open-label, multi-center workflow pilot. Viz HCM will be implemented at each participating site and all conforming incoming ECG recordings within a 6-month enrollment period will be analyzed using Viz HCM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Viz HCM ECG Review and Baseline Effectiveness Cohort
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 217 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Jan 2022to 30 Jun 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: During the 6-month enrollment period, patients who receive an ECG at participating sites will be screened to determine if they meet eligibility criteria. All patients meeting eligibility criteria will be enrolled
Who may be able to join
- Patients aged 18 years of greater at the time of arrival to healthcare facility
- Patients underwent resting 12-lead digital electrocardiogram (ECG) at healthcare facility
Who cannot join
- Patients with poor or incomplete recordings
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, 92037
Centennial Heart Cardiovascular Consultants
Nashville, Tennessee, 37203
The Mount Sinai Hospital
New York, New York, 10029
The Valley Hospital
Ridgewood, New Jersey, 07450
HCA Methodist
San Antonio, Texas, 78249
About this study
This is a prospective, open-label, multi-center workflow pilot. Viz HCM will be implemented at each participating site and all conforming incoming ECG recordings within a 6-month enrollment period will be analyzed using Viz HCM. This workflow pilot provides an opportunity to understand how Viz HCM will be utilized and adopted post-market and to learn the pre- versus post-implementation impact of Viz HCM on HCM clinical workflow.
This pilot is designed to evaluate the implementation of Viz HCM for use in traditional HCM clinical workflow. Findings from this pilot will help inform the following:
- The impact of Viz HCM on HCM clinical workflow
- How Viz HCM will be utilized and adopted post-market
- The diversity in the HCM patient population and the variation in HCM clinical workflow
Read the detailed description
Hypertrophic cardiomyopathy (HCM) is a genetic cardiac disease that causes the walls of the lower heart chambers to thicken and stiffen. As the disease progresses, thickened walls around the left ventricle may block or reduce blood flow to the aorta, potentially interrupting the flow of oxygenated blood to the rest of the body. As a result, the heart must pump harder to overcome this obstruction and supply the body's circulation. HCM is initially suspected by the presence of an abnormal electrocardiogram (ECG) and confirmed by diagnostic imaging showing a left ventricular wall thickness of >15mm (>13mm in relatives of individuals with HCM or those who are genotype positive) that cannot be explained by another cardiac or general disease. The prevalence of HCM in the general population is 1:200 to 1:500 (~750,000 Americans); however only 10-20% of cases are diagnosed, signifying an under-recognition of HCM in clinical practice and thus a need for better disease detection.
Viz HCM is a software device designed to alert and triage suspected HCM patients to the appropriate clinical care team. The device consists of an artificial intelligence algorithm embedded in a standalone mobile application. This is a prospective, open-label, multi-center workflow pilot. Viz HCM will be implemented at each participating site and all conforming incoming ECG recordings within a 6-month enrollment period will be analyzed using Viz HCM. The pilot will measure device utilization based on the percentage of HCM suspected notifications viewed by users. Among the number of viewed Viz suspected HCM cases, data will also be collected on time to follow-up as well as the type, date, and number of follow-up tests after notification. Impact of Viz HCM on clinical workflow will be established by comparing the number of HCM diagnosed patients (based on hospital records over the 6 months prior to site activation) [pre-Viz] to the number of HCM patients (flagged by Viz HCM and confirmed by follow-up transthoracic ECHO and/or CMR diagnostic imaging) after site activation [post-Viz]
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Viz HCM ECG Review, Baseline Effectiveness Cohort
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viz HCM ECG ReviewBehavioural
Viz HCM will auto-alert relevant users to ECGs the algorithm has deemed as suspicious for HCM. Following review of this alert and the patient\'s Medical/Clinical History, the reviewer will take the next Standard of Care action they deem appropriate.
Baseline Effectiveness CohortBehavioural
A review of the timing and clinical details of the diagnostic process for patients diagnosed with HCM before the site began using Viz HCM.
| Study group | Role | What they receive |
|---|---|---|
| pre-Viz | The number of HCM diagnosed patients (based on hospital records over the 6 months prior to site activation with the Viz HCM software) [pre-Viz] Receives: Behavioral: Baseline Effectiveness Cohort | |
| post-Viz | The number of HCM patients (flagged by Viz HCM and confirmed by follow-up transthoracic ECHO and/or CMR diagnostic imaging) after site activation with the Viz HCM software [post-Viz] Receives: Behavioral: Viz HCM ECG Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Viz suspected HCM cases viewed by users
Algorithm performance - sensitivity and specificity of the Viz HCM software
Measured: up to 10 minutes
Number of viewed Viz suspected HCM cases that receive any follow-up action (e.g., schedule test, physician referral)
algorithm processing time
Measured: up to 10 minutes
Secondary outcomes (2)
Number of HCM diagnosed patients (based on hospital records over the 6 months prior to site activation) [pre-Viz]
algorithm sensitivity
Measured: up to 10 minutes
Number of HCM patients (flagged by Viz HCM and confirmed by follow-up transthoracic ECHO and/or CMR diagnostic imaging) [post-Viz]
algorithm specificity
Measured: up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Jan 2022
- Primary completion31 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viz.ai, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600256
- Sponsor's protocol ID
- Viz-HCM-01
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viz HCM (ECG Assist) Utilization Workflow Pilot
- ClinicalTrials.gov ID
- NCT06600256
- Acronym / sponsor ID
- Viz-HCM-01
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Viz.ai, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (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 prospective, open-label, multi-center workflow pilot. Viz HCM will be implemented at each participating site and all conforming incoming ECG recordings within a 6-month enrollment period will be analyzed using Viz HCM. This workflow pilot provides an opportunity to understand how Viz HCM will be utilized and adopted post-market and to learn the pre- versus post-implementation impact of Viz HCM on HCM clinical workflow.
This pilot is designed to evaluate the implementation of Viz HCM for use in traditional HCM clinical workflow. Findings from this pilot will help inform the following:
- The impact of Viz HCM on HCM clinical workflow
- How Viz HCM will be utilized and adopted post-market
- The diversity in the HCM patient population and the variation in HCM clinical workflow
Detailed description
Hypertrophic cardiomyopathy (HCM) is a genetic cardiac disease that causes the walls of the lower heart chambers to thicken and stiffen. As the disease progresses, thickened walls around the left ventricle may block or reduce blood flow to the aorta, potentially interrupting the flow of oxygenated blood to the rest of the body. As a result, the heart must pump harder to overcome this obstruction and supply the body's circulation. HCM is initially suspected by the presence of an abnormal electrocardiogram (ECG) and confirmed by diagnostic imaging showing a left ventricular wall thickness of >15mm (>13mm in relatives of individuals with HCM or those who are genotype positive) that cannot be explained by another cardiac or general disease. The prevalence of HCM in the general population is 1:200 to 1:500 (~750,000 Americans); however only 10-20% of cases are diagnosed, signifying an under-recognition of HCM in clinical practice and thus a need for better disease detection.
Viz HCM is a software device designed to alert and triage suspected HCM patients to the appropriate clinical care team. The device consists of an artificial intelligence algorithm embedded in a standalone mobile application. This is a prospective, open-label, multi-center workflow pilot. Viz HCM will be implemented at each participating site and all conforming incoming ECG recordings within a 6-month enrollment period will be analyzed using Viz HCM. The pilot will measure device utilization based on the percentage of HCM suspected notifications viewed by users. Among the number of viewed Viz suspected HCM cases, data will also be collected on time to follow-up as well as the type, date, and number of follow-up tests after notification. Impact of Viz HCM on clinical workflow will be established by comparing the number of HCM diagnosed patients (based on hospital records over the 6 months prior to site activation) [pre-Viz] to the number of HCM patients (flagged by Viz HCM and confirmed by follow-up transthoracic ECHO and/or CMR diagnostic imaging) after site activation [post-Viz]
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-Viz | – | Behavioral: Baseline Effectiveness CohortThe number of HCM diagnosed patients (based on hospital records over the 6 months prior to site activation with the Viz HCM software) [pre-Viz] |
| post-Viz | – | Behavioral: Viz HCM ECG ReviewThe number of HCM patients (flagged by Viz HCM and confirmed by follow-up transthoracic ECHO and/or CMR diagnostic imaging) after site activation with the Viz HCM software [post-Viz] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- During the 6-month enrollment period, patients who receive an ECG at participating sites will be screened to determine if they meet eligibility criteria. All patients meeting eligibility criteria will be enrolled
Key inclusion criteria (2 listed)
- Patients aged 18 years of greater at the time of arrival to healthcare facility
- Patients underwent resting 12-lead digital electrocardiogram (ECG) at healthcare facility
Key exclusion criteria (1 listed)
- Patients with poor or incomplete recordings
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 |
|---|---|---|
| Viz HCM ECG ReviewViz HCM will auto-alert relevant users to ECGs the algorithm has deemed as suspicious for HCM. Following review of this alert and the patient\'s Medical/Clinical History, the reviewer will take the next Standard of Care action they deem appropriate. | Behavioural | post-Viz |
| Baseline Effectiveness CohortA review of the timing and clinical details of the diagnostic process for patients diagnosed with HCM before the site began using Viz HCM. | Behavioural | pre-Viz |
Primary outcome
Percentage of Viz suspected HCM cases viewed by users
Time frame: up to 10 minutes
Algorithm performance - sensitivity and specificity of the Viz HCM software
Number of viewed Viz suspected HCM cases that receive any follow-up action (e.g., schedule test, physician referral)
Time frame: up to 10 minutes
algorithm processing time
2 secondary outcomes
Number of HCM diagnosed patients (based on hospital records over the 6 months prior to site activation) [pre-Viz]
Time frame: up to 10 minutes
Number of HCM patients (flagged by Viz HCM and confirmed by follow-up transthoracic ECHO and/or CMR diagnostic imaging) [post-Viz]
Time frame: up to 10 minutes
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 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by Viz.ai, Inc. at 5 sites 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 2 inclusion and 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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?
Percentage of Viz suspected HCM cases viewed by users (time frame: up to 10 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 19 Sep 2024.