NCT07103057

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Viz.ai, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-06-13
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-08-05
• Last updated: 2025-08-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study