Viz HCM (ECG Assist) Utilization Workflow Pilot

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

Study Overview

• Status: Completed
• Conditions: Hypertrophic Cardiomyopathy
• Intervention / Treatment: Behavioral: Baseline Effectiveness Cohort; Behavioral: Viz HCM ECG Review

Detailed Description

Hypertrophic cardiomyopathy (HCM) is a genetic cardiac disease that causes the walls of the lower heart chambers to thicken and stiffen. As the disease progresses, thickened walls around the left ventricle may block or reduce blood flow to the aorta, potentially interrupting the flow of oxygenated blood to the rest of the body. As a result, the heart must pump harder to overcome this obstruction and supply the body's circulation. HCM is initially suspected by the presence of an abnormal electrocardiogram (ECG) and confirmed by diagnostic imaging showing a left ventricular wall thickness of >15mm (>13mm in relatives of individuals with HCM or those who are genotype positive) that cannot be explained by another cardiac or general disease. The prevalence of HCM in the general population is 1:200 to 1:500 (~750,000 Americans); however only 10-20% of cases are diagnosed, signifying an under-recognition of HCM in clinical practice and thus a need for better disease detection.

Viz HCM is a software device designed to alert and triage suspected HCM patients to the appropriate clinical care team. The device consists of an artificial intelligence algorithm embedded in a standalone mobile application. 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. The pilot will measure device utilization based on the percentage of HCM suspected notifications viewed by users. Among the number of viewed Viz suspected HCM cases, data will also be collected on time to follow-up as well as the type, date, and number of follow-up tests after notification. Impact of Viz HCM on clinical workflow will be established by comparing the number of HCM diagnosed patients (based on hospital records over the 6 months prior to site activation) [pre-Viz] to the number of HCM patients (flagged by Viz HCM and confirmed by follow-up transthoracic ECHO and/or CMR diagnostic imaging) after site activation [post-Viz]

• Study Type: Observational
• Enrollment (Actual): 217

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego Sulpizio Cardiovascular Center
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New York
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Centennial Heart Cardiovascular Consultants
  • Texas
    • San Antonio, Texas, United States, 78249
      • HCA Methodist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

During the 6-month enrollment period, patients who receive an ECG at participating sites will be screened to determine if they meet eligibility criteria. All patients meeting eligibility criteria will be enrolled

Description

Inclusion Criteria:

• Patients aged 18 years of greater at the time of arrival to healthcare facility
• Patients underwent resting 12-lead digital electrocardiogram (ECG) at healthcare facility

Exclusion Criteria:

• Patients with poor or incomplete recordings

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pre-Viz; The number of HCM diagnosed patients (based on hospital records over the 6 months prior to site activation with the Viz HCM software) [pre-Viz]	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.
post-Viz; The number of HCM patients (flagged by Viz HCM and confirmed by follow-up transthoracic ECHO and/or CMR diagnostic imaging) after site activation with the Viz HCM software [post-Viz]	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Viz suspected HCM cases viewed by users	Algorithm performance - sensitivity and specificity of the Viz HCM software	up to 10 minutes
Number of viewed Viz suspected HCM cases that receive any follow-up action (e.g., schedule test, physician referral)	algorithm processing time	up to 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of HCM diagnosed patients (based on hospital records over the 6 months prior to site activation) [pre-Viz]	algorithm sensitivity	up to 10 minutes
Number of HCM patients (flagged by Viz HCM and confirmed by follow-up transthoracic ECHO and/or CMR diagnostic imaging) [post-Viz]	algorithm specificity	up to 10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type, date, and number of follow-up tests after HCM notification	exploratory endpoint	180 days
Time from HCM notification view to follow-up testing and/or documented diagnosis	exploratory endpoint	up to 48 hours
User satisfaction (Viz HCM Physician Satisfaction Survey)	exploratory endpoint	180 days
Descriptive statistics by site and by patient demographic breakdown (e.g., race/ethnicity)	exploratory endpoint	180 days

Collaborators and Investigators

• Sponsor: Viz.ai, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: Viz-HCM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No