VIZ ACCESS HCM multi-site registry of patients with ECG alerts for hypertrophic cardiomyopathy
ACCESS HCM: Real World Evidence for Artificial-Intelligence-assisted Screening and Access to Care for HCM - A Multi-Site Registry
This registry will collect information on adults whose ECGs are flagged by the Viz HCM AI to see if those alerts match real HCM diagnoses and affect patient care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Viz.ai, Inc. Industry-sponsored |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT07103057 on ClinicalTrials.gov |
What this trial studies
VIZ ACCESS HCM is an observational, multi-center registry enrolling adults with resting 12-lead digital ECGs flagged by the Viz HCM algorithm. Participants are categorized into newly diagnosed, previously diagnosed, suspected, unlikely HCM, and alerts-not-reviewed cohorts and clinical, diagnostic, and economic data are collected from medical records. The registry follows diagnostic workups, downstream testing, management decisions, and short-term outcomes to describe real-world handling of AI alerts. Findings are intended to inform best practices for integrating AI ECG screening into clinical workflows and estimate potential population and economic impacts.
Who should consider this trial
Good fit: Adults (18+) whose resting 12-lead digital ECG was flagged by Viz HCM — including newly diagnosed, previously diagnosed, suspected, unlikely, or alerts not reviewed — are the ideal candidates.
Not a fit: People under 18, those without a digital ECG flagged by Viz HCM, or patients whose care is already stable and unlikely to change with additional diagnostic information are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could help clinicians use AI ECG alerts more effectively to find undiagnosed HCM earlier and streamline follow-up care.
How similar studies have performed: Prior research has shown AI ECG tools can detect signals suggestive of HCM, but multi-site real-world registries examining how to integrate these alerts into care pathways are limited.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Atlanta, Georgia and 2 other locations
- Emory University — Atlanta, Georgia, United States (Not_yet_recruiting)
- North Shore University Health System — Evanston, Illinois, United States (Recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Milind Desai, MD — The Cleveland Clinic
- Study coordinator: Sloane Smith-Saunders, MBA, MPH
- Email: sloane.smith-saunders@viz.ai
- Phone: (754) 307-6336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.