Clinical trial NCT06600256: Viz HCM (ECG Assist) Utilization Workflow Pilot
Official title: Viz HCM (ECG Assist) Utilization Workflow Pilot
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: Viz.ai, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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

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 \[post-Viz\]

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Viz suspected HCM cases viewed by users
timeFrame: up to 10 minutes
measure: Number of viewed Viz suspected HCM cases that receive any follow-up action (e.g., schedule test, physician referral)
timeFrame: up to 10 minutes
Secondary outcomes:
measure: Number of HCM diagnosed patients (based on hospital records over the 6 months prior to site activation) [pre-Viz]
timeFrame: up to 10 minutes
measure: Number of HCM patients (flagged by Viz HCM and confirmed by follow-up transthoracic ECHO and/or CMR diagnostic imaging) [post-Viz]
timeFrame: up to 10 minutes
Other outcomes:
measure: Type, date, and number of follow-up tests after HCM notification
timeFrame: 180 days
measure: Time from HCM notification view to follow-up testing and/or documented diagnosis
timeFrame: up to 48 hours
measure: User satisfaction (Viz HCM Physician Satisfaction Survey)
timeFrame: 180 days
measure: Descriptive statistics by site and by patient demographic breakdown (e.g., race/ethnicity)
timeFrame: 180 days
Locations:
city: La Jolla
country: United States
facility: UC San Diego Sulpizio Cardiovascular Center
state: California
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Nashville
country: United States
facility: Centennial Heart Cardiovascular Consultants
state: Tennessee
city: San Antonio
country: United States
facility: HCA Methodist
state: Texas
Study officials:
References: