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Recruiting NCT07103057

VIZ ACCESS HCM - Multi-Site Registry

— Observational Hypertrophic Cardiomyopathy

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Viz HCM.
Who it may be relevant to
Registry conditions: Hypertrophic Cardiomyopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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]
  • 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]
Secondary outcome measures (3)
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 3 centers
  • Emory University — Atlanta
  • North Shore University Health System — Evanston
  • Thomas Jefferson University — Philadelphia

Identifiers

NCT: NCT07103057 · Viz-HCM-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗