Recruiting

Observational Study

Sponsor:

Viz.ai, Inc.

Code:

NCT07103057

Conditions

Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Viz HCM

Study Details

Brief summary:

To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM. HCM is underdiagnosed in the community and AI algorithms have been developed as screening tools. However, it is not well understood how to best integrate AI screening tools and their potential impact.

Conditions

Hypertrophic Cardiomyopathy

Study ID

NCT07103057

Start date

Jun 13, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

All Cohorts

  • Patients aged 18+ years at time of arrival to healthcare facility
  • Patients with a resting 12-lead digital electrocardiogram (ECG) that is flagged by Viz HCM for HCM suspicion

Additional cohort-specific criteria:

Cohort 1 - Newly Diagnosed Patients

  • Patients have been diagnosed with HCM after the Viz HCM implementation
  • Written informed consent is obtained prior to data collection

Cohort 2 - Previously Diagnosed Patients ● Prior diagnosis of HCM as evidenced by clinical diagnosis documentation prior to Viz HCM implementation

Cohort 3 - Suspected and Not Diagnosed Patients

● Patients did not receive sufficient clinical workup for HCM diagnosis confirmation

Cohort 4 - Unlikely HCM ● Patient ECG moved to 'Unlikely HCM' group within Viz by site study staff following HCM alert review

Cohort 5 - Alerts Not Reviewed

● HCM alert not reviewed by site study staff during study enrollment period

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1- Newly Diagnosed Patients

This cohort will consist of individuals who are newly diagnosed with HCM after the site began using Viz HCM. These patients will serve as a key population to assess the AI tool's impact on diagnoses, timeliness, and subsequent initiation of treatment. Data collected will include pre-diagnostic clinical indicators, diagnostic pathways, and treatment decisions following diagnosis. This cohort will begin to describe patient access to care and the clinical outcomes following a new HCM diagnosis in an AI-augmented clinical workflow.

Cohort 2 - Previously Diagnosed Patients

Patients in this cohort will have an existing diagnosis of HCM prior to the start of using Viz HCM. This group will allow for the evaluation of how the AI tool may influence ongoing management strategies, such as treatment adjustments, monitoring practices, risk stratification, and clinical outcomes. The cohort will also help assess whether the AI tool facilitates optimization of care by identifying missed opportunities or previously unrecognized complications.

Cohort 3 - Suspected and Not Diagnosed Patients

This cohort will include patients who were suspected by Viz HCM users of having underlying HCM, but clinical work-up sufficient to produce a diagnosis of HCM (including imaging and/or genetic testing) did not occur within the data collection period. Data collected will focus on diagnostic pathways, attempts made to coordinate care, and categorical barriers to care.

Cohort 4 - Unlikely HCM

This cohort will look at a subset of randomly selected patients who are suspected by Viz HCM of having underlying HCM but are moved to the subgroup 'Unlikely HCM' within the Viz app/web by a clinician. After 1 year of study enrollment, a list will be created by Viz and shared with study teams for collection of additional minimal data including age, sex, reason for unlikely HCM (via chat), demographics (race, ethnicity) and reason for ECG.

Cohort 5 - Alerts Not Reviewed

This cohort will look at a subset of randomly selected patients who are suspected by Viz HCM of having underlying HCM, but the alert is never reviewed by a clinician. After 1 year of study enrollment, a list will be created by Viz and shared with study teams for collection of additional minimal data including age, sex, demographics (race, ethnicity) and reason for ECG.

Interventions

Viz HCM

Viz HCM is a Software as a Medical Device (SaMD) intended to receive 12-lead ECG recordings collected as part of a routine clinical assessment and analyze them in parallel to the standard of care. The device uses a machine learning based algorithm to analyze 12-lead ECGs and identify ECGs with suspected HCM.

Primary outcome measure

  • Clinical characteristics of Viz HCM AI screening on HCM diagnosis [ Time Frame: Up to 3 years ]
  • Clinical characteristics of Viz HCM AI screening on medical workup. [ Time Frame: Up to 3 years ]
  • Clinical characteristics of Viz HCM AI screening on treatment plans. [ Time Frame: Up to 3 years ]
  • Clinical characteristics of Viz HCM AI screening on closed care pathways [ Time Frame: Up to 3 years ]
  • Population evaluation for access to care by socioeconomic status at the time of diagnosis. [ Time Frame: Up to 3 years ]
  • Population evaluation for access to care by clinical stage of HCM at time of diagnosis. [ Time Frame: Up to 3 years ]
  • Healthcare utilization and health economic outcomes- medical clinic visits [ Time Frame: Up to 3 years ]
  • Health economics outcome as captured by associated testing modalities [ Time Frame: Up to 3 years ]
  • Health economics outcome as captured by hospitalization data [ Time Frame: Up to 3 years ]
  • Health economics outcome as captured by ICD placement data [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Sloane Smith-Saunders, MBA, MPH

‪(754) 307-6336‬sloane.smith-saunders@viz.ai

Ethan Carter, BSN

‪(415) 409-9369‬ethan.carter@viz.ai

Locations

North Shore University Health System

Recruiting

Evanston, Illinois, United States, 60201

Contacts

847-570-2000

Principal Investigator:

Robert Gordon, MD

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

800-533-3669

Principal Investigator:

David Shipon, MD

More Information

Sponsor

Viz.ai, Inc.

Last update posted

Aug 17, 2025

Last verified

Aug, 2025

Keywords

  • Artificial Intelligence
  • HCM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Viz.ai, Inc. on 2025-08-17.