No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
Viz.ai, Inc. · Industry
Who this trial is looking for
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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.
Trial Locations
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Status
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 w…
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
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