Hypertrophic CardiomyopathyNCT07103057
VIZ ACCESS HCM - Multi-Site Registry
An observational study of Hypertrophic Cardiomyopathy, run by Viz.ai, Inc. at 3 sites in United States.
Trial summary
To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM. HCM is underdiagnosed in the community and AI algorithms have been developed as screening tools. 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
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jun 2025to 17 Sep 2026
- 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: Individuals who have an ECG that has been flagged by Viz HCM.
All Cohorts
- Patients aged 18+ years at time of arrival to healthcare facility
- Patients with a resting 12-lead digital electrocardiogram (ECG) that is flagged by Viz HCM for HCM suspicion
Additional cohort-specific criteria:
Cohort 1 - Newly Diagnosed Patients
- Patients have been diagnosed with HCM after the Viz HCM implementation
- Written informed consent is obtained prior to data collection
Cohort 2 - Previously Diagnosed Patients ● Prior diagnosis of HCM as evidenced by clinical diagnosis documentation prior to Viz HCM implementation
Cohort 3 - Suspected and Not Diagnosed Patients
● Patients did not receive sufficient clinical workup for HCM diagnosis confirmation
Cohort 4 - Unlikely HCM ● Patient ECG moved to 'Unlikely HCM' group within Viz by site study staff following HCM alert review
Cohort 5 - Alerts Not Reviewed
● HCM alert not reviewed by site study staff during study enrollment period
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30322
North Shore University Health System
Evanston, Illinois, 60201
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: ACCESS HCM: Real World Evidence for Artificial-Intelligence-assisted Screening and Access to Care for HCM - A Multi-Site Registry
To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM. HCM is underdiagnosed in the community and AI algorithms have been developed as screening tools. However, it is not well understood how to best integrate AI screening tools and their potential impact.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Viz HCM
- Keywords
- Artificial Intelligence, HCM
- 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 HCMDevice
Viz HCM is a Software as a Medical Device (SaMD) intended to receive 12-lead ECG recordings collected as part of a routine clinical assessment and analyze them in parallel to the standard of care. The device uses a machine learning based algorithm to analyze 12-lead ECGs and identify ECGs with suspected HCM.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1- Newly Diagnosed Patients | This cohort will consist of individuals who are newly diagnosed with HCM after the site began using Viz HCM. These patients will serve as a key population to assess the AI tool's impact on diagnoses, timeliness, and subsequent initiation of treatment. Data collected will include pre-diagnostic clinical indicators, diagnostic pathways, and treatment decisions following diagnosis. This cohort will begin to describe patient access to care and the clinical outcomes following a new HCM diagnosis in an AI-augmented clinical workflow. Receives: Device: Viz HCM | |
| Cohort 2 - Previously Diagnosed Patients | Patients in this cohort will have an existing diagnosis of HCM prior to the start of using Viz HCM. This group will allow for the evaluation of how the AI tool may influence ongoing management strategies, such as treatment adjustments, monitoring practices, risk stratification, and clinical outcomes. The cohort will also help assess whether the AI tool facilitates optimization of care by identifying missed opportunities or previously unrecognized complications. Receives: Device: Viz HCM | |
| Cohort 3 - Suspected and Not Diagnosed Patients | This cohort will include patients who were suspected by Viz HCM users of having underlying HCM, but clinical work-up sufficient to produce a diagnosis of HCM (including imaging and/or genetic testing) did not occur within the data collection period. Data collected will focus on diagnostic pathways, attempts made to coordinate care, and categorical barriers to care. Receives: Device: Viz HCM | |
| Cohort 4 - Unlikely HCM | This cohort will look at a subset of randomly selected patients who are suspected by Viz HCM of having underlying HCM but are moved to the subgroup 'Unlikely HCM' within the Viz app/web by a clinician. After 1 year of study enrollment, a list will be created by Viz and shared with study teams for collection of additional minimal data including age, sex, reason for unlikely HCM (via chat), demographics (race, ethnicity) and reason for ECG. Receives: Device: Viz HCM | |
| Cohort 5 - Alerts Not Reviewed | This cohort will look at a subset of randomly selected patients who are suspected by Viz HCM of having underlying HCM, but the alert is never reviewed by a clinician. After 1 year of study enrollment, a list will be created by Viz and shared with study teams for collection of additional minimal data including age, sex, demographics (race, ethnicity) and reason for ECG. Receives: Device: Viz HCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics of Viz HCM AI screening on HCM diagnosis
To describe the clinical characteristics of patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Measured: Up to 3 years
Clinical characteristics of Viz HCM AI screening on medical workup.
To describe the clinical characteristics of medical workup for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Measured: Up to 3 years
Clinical characteristics of Viz HCM AI screening on treatment plans.
To describe the clinical characteristics of treatment plans for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Measured: Up to 3 years
Clinical characteristics of Viz HCM AI screening on closed care pathways
To describe the clinical characteristics of closed care pathways (patients diagnosed who receive treatment) for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Measured: Up to 3 years
Population evaluation for access to care by socioeconomic status at the time of diagnosis.
To describe HCM access to care by socioeconomic status at the time of diagnosis.
Measured: Up to 3 years
Population evaluation for access to care by clinical stage of HCM at time of diagnosis.
Population evaluation for access to care by clinical stage of HCM at time of diagnosis.
Measured: Up to 3 years
Healthcare utilization and health economic outcomes- medical clinic visits
To describe healthcare utilization and economic outcomes as captured by medical clinic visits, associated testing (e.g., echocardiogram, cardiac MRI, laboratory and genetic screening), hospitalization, and ICD placement for primary and secondary prevention for sudden cardiac death.
Measured: Up to 3 years
Health economics outcome as captured by associated testing modalities
To describe healthcare utilization and economic outcomes as captured by associated testing
Measured: Up to 3 years
Health economics outcome as captured by hospitalization data
To describe healthcare utilization and economic outcomes as captured by hospitalization data
Measured: Up to 3 years
Health economics outcome as captured by ICD placement data
To describe healthcare utilization and economic outcomes as captured by ICD placement for primary and secondary prevention for sudden cardiac death.
Measured: Up to 3 years
Secondary outcomes (3)
Implementation science - percentage of alerts viewed
Measured: Up to 2 years
Implementation science - number of active users over time
Measured: Up to 2 years
Implementation science - reasons for user-indicated actions, where documented
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start13 Jun 2025
- Primary completion17 Sep 2026
- Study completion17 Sep 2026
Why it stopped: Sponsor company opted to shift design into single center investigator initiated study focus.
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
- 17 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
- NCT07103057
- Sponsor's protocol ID
- Viz-HCM-10
- Status last verified
- Sep 2026
- First submitted
- 13 May 2025
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCESS HCM: Real World Evidence for Artificial-Intelligence-assisted Screening and Access to Care for HCM - A Multi-Site Registry
- ClinicalTrials.gov ID
- NCT07103057
- Acronym / sponsor ID
- Viz-HCM-10
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Artificial Intelligence, HCM
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor company opted to shift design into single center investigator initiated study focus.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Viz.ai, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 17 Sep 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 5 Aug 2025 (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.
To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM. HCM is underdiagnosed in the community and AI algorithms have been developed as screening tools. However, it is not well understood how to best integrate AI screening tools and their potential impact.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1- Newly Diagnosed Patients | – | Device: Viz HCMThis cohort will consist of individuals who are newly diagnosed with HCM after the site began using Viz HCM. These patients will serve as a key population to assess the AI tool's impact on diagnoses, timeliness, and subsequent initiation of treatment. Data collected will include pre-diagnostic clinical indicators, diagnostic pathways, and treatment decisions following diagnosis. This cohort will begin to describe patient access to care and the clinical outcomes following a new HCM diagnosis in an AI-augmented clinical workflow. |
| Cohort 2 - Previously Diagnosed Patients | – | Device: Viz HCMPatients in this cohort will have an existing diagnosis of HCM prior to the start of using Viz HCM. This group will allow for the evaluation of how the AI tool may influence ongoing management strategies, such as treatment adjustments, monitoring practices, risk stratification, and clinical outcomes. The cohort will also help assess whether the AI tool facilitates optimization of care by identifying missed opportunities or previously unrecognized complications. |
| Cohort 3 - Suspected and Not Diagnosed Patients | – | Device: Viz HCMThis cohort will include patients who were suspected by Viz HCM users of having underlying HCM, but clinical work-up sufficient to produce a diagnosis of HCM (including imaging and/or genetic testing) did not occur within the data collection period. Data collected will focus on diagnostic pathways, attempts made to coordinate care, and categorical barriers to care. |
| Cohort 4 - Unlikely HCM | – | Device: Viz HCMThis cohort will look at a subset of randomly selected patients who are suspected by Viz HCM of having underlying HCM but are moved to the subgroup 'Unlikely HCM' within the Viz app/web by a clinician. After 1 year of study enrollment, a list will be created by Viz and shared with study teams for collection of additional minimal data including age, sex, reason for unlikely HCM (via chat), demographics (race, ethnicity) and reason for ECG. |
| Cohort 5 - Alerts Not Reviewed | – | Device: Viz HCMThis cohort will look at a subset of randomly selected patients who are suspected by Viz HCM of having underlying HCM, but the alert is never reviewed by a clinician. After 1 year of study enrollment, a list will be created by Viz and shared with study teams for collection of additional minimal data including age, sex, demographics (race, ethnicity) and reason for ECG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have an ECG that has been flagged by Viz HCM.
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 HCMViz HCM is a Software as a Medical Device (SaMD) intended to receive 12-lead ECG recordings collected as part of a routine clinical assessment and analyze them in parallel to the standard of care. The device uses a machine learning based algorithm to analyze 12-lead ECGs and identify ECGs with suspected HCM. | Device | Cohort 1- Newly Diagnosed Patients, Cohort 2 - Previously Diagnosed Patients, Cohort 3 - Suspected and Not Diagnosed Patients, Cohort 4 - Unlikely HCM, Cohort 5 - Alerts Not Reviewed |
Primary outcome
Clinical characteristics of Viz HCM AI screening on HCM diagnosis
Time frame: Up to 3 years
To describe the clinical characteristics of patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Clinical characteristics of Viz HCM AI screening on medical workup.
Time frame: Up to 3 years
To describe the clinical characteristics of medical workup for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Clinical characteristics of Viz HCM AI screening on treatment plans.
Time frame: Up to 3 years
To describe the clinical characteristics of treatment plans for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Clinical characteristics of Viz HCM AI screening on closed care pathways
Time frame: Up to 3 years
To describe the clinical characteristics of closed care pathways (patients diagnosed who receive treatment) for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Population evaluation for access to care by socioeconomic status at the time of diagnosis.
Time frame: Up to 3 years
To describe HCM access to care by socioeconomic status at the time of diagnosis.
Population evaluation for access to care by clinical stage of HCM at time of diagnosis.
Time frame: Up to 3 years
Population evaluation for access to care by clinical stage of HCM at time of diagnosis.
Healthcare utilization and health economic outcomes- medical clinic visits
Time frame: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by medical clinic visits, associated testing (e.g., echocardiogram, cardiac MRI, laboratory and genetic screening), hospitalization, and ICD placement for primary and secondary prevention for sudden cardiac death.
Health economics outcome as captured by associated testing modalities
Time frame: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by associated testing
Health economics outcome as captured by hospitalization data
Time frame: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by hospitalization data
Health economics outcome as captured by ICD placement data
Time frame: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by ICD placement for primary and secondary prevention for sudden cardiac death.
3 secondary outcomes
Implementation science - percentage of alerts viewed
Time frame: Up to 2 years
Implementation science - number of active users over time
Time frame: Up to 2 years
Implementation science - reasons for user-indicated actions, where documented
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Sponsor company opted to shift design into single center investigator initiated study focus.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 3 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?
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: stopped early, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: Sponsor company opted to shift design into single center investigator initiated study focus.). 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?
Clinical characteristics of Viz HCM AI screening on HCM diagnosis (time frame: Up to 3 years). The study lists 10 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 23 Sep 2026.