Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT07103057
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07103057
Study Brief:
Protocol Section:
NCT07103057