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RECRUITINGOBSERVATIONAL

VIZ ACCESS HCM - Multi-Site Registry

ACCESS HCM: Real World Evidence for Artificial-Intelligence-assisted Screening and Access to Care for HCM - A Multi-Site Registry

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

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.

Locations (3)

Emory University
Atlanta, Georgia, United States
North Shore University Health System
Evanston, Illinois, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States