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VIZ ACCESS HCM - Multi-Site Registry
Sponsor: Viz.ai, Inc.
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.
Official title: ACCESS HCM: Real World Evidence for Artificial-Intelligence-assisted Screening and Access to Care for HCM - A Multi-Site Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2025-06-13
Completion Date
2028-12
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
Viz HCM
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)
Emory University
Atlanta, Georgia, United States
North Shore University Health System
Evanston, Illinois, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States