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.
Study Type
OBSERVATIONAL
Enrollment
500
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.
Emory University
Atlanta, Georgia, United States
NOT_YET_RECRUITINGNorth Shore University Health System
Evanston, Illinois, United States
RECRUITINGThomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGClinical characteristics of Viz HCM AI screening on HCM diagnosis
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.
Time frame: Up to 3 years
Clinical characteristics of Viz HCM AI screening on medical workup.
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.
Time frame: Up to 3 years
Clinical characteristics of Viz HCM AI screening on treatment plans.
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.
Time frame: Up to 3 years
Clinical characteristics of Viz HCM AI screening on closed care pathways
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.
Time frame: Up to 3 years
Population evaluation for access to care by socioeconomic status at the time of diagnosis.
To describe HCM 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.
Population evaluation for access to care by clinical stage of HCM at time of diagnosis.
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Healthcare utilization and health economic outcomes- medical clinic visits
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.
Time frame: Up to 3 years
Health economics outcome as captured by associated testing modalities
To describe healthcare utilization and economic outcomes as captured by associated testing
Time frame: Up to 3 years
Health economics outcome as captured by hospitalization data
To describe healthcare utilization and economic outcomes as captured by hospitalization data
Time frame: Up to 3 years
Health economics outcome as captured by ICD placement data
To describe healthcare utilization and economic outcomes as captured by ICD placement for primary and secondary prevention for sudden cardiac death.
Time frame: Up to 3 years
Implementation science - percentage of alerts viewed
Time frame: Up to 2 years
Implementation science - number of active users over time
Time frame: Up to 2 years
Implementation science - reasons for user-indicated actions, where documented
Time frame: Up to 2 years