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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viz HCM | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation science - percentage of alerts viewed | Up to 2 years | |
| Implementation science - number of active users over time | Up to 2 years | |
| Implementation science - reasons for user-indicated actions, where documented |
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All Cohorts
Additional cohort-specific criteria:
Cohort 1 - Newly Diagnosed Patients
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
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Individuals who have an ECG that has been flagged by Viz HCM.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sloane Smith-Saunders, MBA, MPH | Contact | (754) 307-6336 | sloane.smith-saunders@viz.ai | |
| Ethan Carter, BSN | Contact | (415) 409-9369 | ethan.carter@viz.ai |
| Name | Affiliation | Role |
|---|---|---|
| Milind Desai, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Not yet recruiting | Atlanta | Georgia | 30322 | United States |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| 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. |
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| 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. | 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 | Up to 3 years |
| Health economics outcome as captured by hospitalization data | To describe healthcare utilization and economic outcomes as captured by hospitalization data | 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. | Up to 3 years |
| Up to 2 years |
| North Shore University Health System | Recruiting | Evanston | Illinois | 60201 | United States |
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| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |