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Viz HCM (ECG Assist) Utilization Workflow Pilot

NCT06600256 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 217

Last updated 2024-09-19

No results posted yet for this study

Summary

This is a prospective, open-label, multi-center workflow pilot. Viz HCM will be implemented at each participating site and all conforming incoming ECG recordings within a 6-month enrollment period will be analyzed using Viz HCM. This workflow pilot provides an opportunity to understand how Viz HCM will be utilized and adopted post-market and to learn the pre- versus post-implementation impact of Viz HCM on HCM clinical workflow.

This pilot is designed to evaluate the implementation of Viz HCM for use in traditional HCM clinical workflow. Findings from this pilot will help inform the following:

* The impact of Viz HCM on HCM clinical workflow
* How Viz HCM will be utilized and adopted post-market
* The diversity in the HCM patient population and the variation in HCM clinical workflow

Conditions

Interventions

BEHAVIORAL

Viz HCM ECG Review

Viz HCM will auto-alert relevant users to ECGs the algorithm has deemed as suspicious for HCM. Following review of this alert and the patient\'s Medical/Clinical History, the reviewer will take the next Standard of Care action they deem appropriate.

BEHAVIORAL

Baseline Effectiveness Cohort

A review of the timing and clinical details of the diagnostic process for patients diagnosed with HCM before the site began using Viz HCM.

Sponsors & Collaborators

  • Viz.ai, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2024-03-31
Completion
2024-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06600256 on ClinicalTrials.gov