VIZ ACCESS HCM - Multi-Site Registry
ConditionHypertrophic Cardiomyopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorViz.ai, Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Patients have been diagnosed with HCM after the Viz HCM implementation
Written informed consent is obtained prior to data collection
Disqualifiers
None
Trial population
Individuals who have an ECG that has been flagged by Viz HCM.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Viz HCM
DeviceViz 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.
Treatment groups
500 Participants
are divided into 5 treatment groupsGroup A: Cohort 1- Newly Diagnosed Patients1 intervention
Group B: Cohort 2 - Previously Diagnosed Patients1 intervention
Group C: Cohort 3 - Suspected and Not Diagnosed Patients1 intervention
Group D: Cohort 4 - Unlikely HCM1 intervention
Group E: Cohort 5 - Alerts Not Reviewed1 intervention
Trial outcomes
Primary outcomes
1
Clinical 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 years2
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 years3
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 years4
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 yearsSecondary outcomes
1
Implementation science - percentage of alerts viewed
Time frame
Up to 2 years2
Implementation science - number of active users over time
Time frame
Up to 2 years3
Implementation science - reasons for user-indicated actions, where documented
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov