VIZ ACCESS HCM - Multi-Site Registry
ACCESS HCM: Real World Evidence for Artificial-Intelligence-assisted Screening and Access to Care for HCM - A Multi-Site Registry
1 other identifier
observational
500
1 country
3
Brief 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. However, it is not well understood how to best integrate AI screening tools and their potential impact.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2025
CompletedStudy Start
First participant enrolled
June 13, 2025
CompletedFirst Posted
Study publicly available on registry
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
August 17, 2025
August 1, 2025
3.5 years
May 13, 2025
August 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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.
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
Secondary Outcomes (3)
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
Up to 2 years
Study Arms (5)
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.
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.
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.
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.
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.
Interventions
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.
Eligibility Criteria
Individuals who have an ECG that has been flagged by Viz HCM.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Viz.ai, Inc.lead
Study Sites (3)
Emory University
Atlanta, Georgia, 30322, United States
North Shore University Health System
Evanston, Illinois, 60201, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Milind Desai, MD
The Cleveland Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2025
First Posted
August 5, 2025
Study Start
June 13, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
August 17, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share