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
Viz.ai, Inc.
500 participants
Jun 13, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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
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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.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07103057