Viz HCM (ECG Assist) Utilization Workflow Pilot
1 other identifier
observational
217
1 country
5
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedFirst Submitted
Initial submission to the registry
September 12, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedSeptember 19, 2024
September 1, 2024
2.2 years
September 12, 2024
September 12, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Number of HCM diagnosed patients (based on hospital records over the 6 months prior to site activation) [pre-Viz]
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]
up to 10 minutes
Other Outcomes (4)
Type, date, and number of follow-up tests after HCM notification
180 days
Time from HCM notification view to follow-up testing and/or documented diagnosis
up to 48 hours
User satisfaction (Viz HCM Physician Satisfaction Survey)
180 days
- +1 more other outcomes
Study Arms (2)
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) \[pre-Viz\]
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 \[post-Viz\]
Interventions
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.
A review of the timing and clinical details of the diagnostic process for patients diagnosed with HCM before the site began using Viz HCM.
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Patients with poor or incomplete recordings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viz.ai, Inc.lead
Study Sites (5)
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, 92037, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
Centennial Heart Cardiovascular Consultants
Nashville, Tennessee, 37203, United States
HCA Methodist
San Antonio, Texas, 78249, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2024
First Posted
September 19, 2024
Study Start
January 10, 2022
Primary Completion
March 31, 2024
Study Completion
June 30, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09