Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-03 @ 9:13 AM
Study NCT ID:
NCT06600256
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Viz HCM (ECG Assist) Utilization Workflow Pilot
Sponsor:
Viz.ai, Inc.
Organization:
Study Overview
Official Title:
Viz HCM (ECG Assist) Utilization Workflow Pilot
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 \[post-Viz\]
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: