VIZ ACCESS HCM - Multi-Site Registry

Viz.ai

Status: Enrolling

Conditions: Hypertrophic Cardiomyopathy

Treatments: Device: Viz HCM

Study type: Observational

Funder types: Industry

Identifiers

NCT07103057

Viz-HCM-10

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 design

500 participants in 5 patient groups

Cohort 1- Newly Diagnosed Patients

Description:

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.

Treatment:

Device: Viz HCM

Cohort 2 - Previously Diagnosed Patients

Description:

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.

Treatment:

Device: Viz HCM

Cohort 3 - Suspected and Not Diagnosed Patients

Description:

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.

Treatment:

Device: Viz HCM

Cohort 4 - Unlikely HCM

Description:

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.

Treatment:

Device: Viz HCM

Cohort 5 - Alerts Not Reviewed

Description:

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.

Treatment:

Device: Viz HCM