NCT07103057 · Viz.ai, Inc.
VIZ ACCESS HCM - Multi-Site Registry
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Clinical characteristics of Viz HCM AI screening on HCM diagnosis
Time frame: Up to 3 years
To describe the clinical characteristics of patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Clinical characteristics of Viz HCM AI screening on medical workup.
Time frame: Up to 3 years
To describe the clinical characteristics of medical workup for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Clinical characteristics of Viz HCM AI screening on treatment plans.
Time frame: Up to 3 years
To describe the clinical characteristics of treatment plans for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Clinical characteristics of Viz HCM AI screening on closed care pathways
Time frame: Up to 3 years
To describe the clinical characteristics of closed care pathways (patients diagnosed who receive treatment) for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM.
Population evaluation for access to care by socioeconomic status at the time of diagnosis.
Time frame: Up to 3 years
To describe HCM access to care by socioeconomic status at the time of diagnosis.
Population evaluation for access to care by clinical stage of HCM at time of diagnosis.
Time frame: Up to 3 years
Population evaluation for access to care by clinical stage of HCM at time of diagnosis.
Healthcare utilization and health economic outcomes- medical clinic visits
Time frame: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by medical clinic visits, associated testing (e.g., echocardiogram, cardiac MRI, laboratory and genetic screening), hospitalization, and ICD placement for primary and secondary prevention for sudden cardiac death.
Health economics outcome as captured by associated testing modalities
Time frame: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by associated testing
Health economics outcome as captured by hospitalization data
Time frame: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by hospitalization data
Health economics outcome as captured by ICD placement data
Time frame: Up to 3 years
To describe healthcare utilization and economic outcomes as captured by ICD placement for primary and secondary prevention for sudden cardiac death.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Atlanta, Georgia
- Evanston, Illinois
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2025 · Source of record for eligibility and locations