VIZ ACCESS HCM - Multi-Site Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Clinical characteristics of Viz HCM AI screening on HCM diagnosis — 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. — 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. — 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 — 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. — 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. — 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 — 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 — Up to 3 years
  To describe healthcare utilization and economic outcomes as captured by associated testing
• Health economics outcome as captured by hospitalization data — 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 — 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.

Trial sites (3)

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