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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT04548804
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must be ≥ 18 years old, have either a history of VTAs or be at risk of VTAs and have one of the following diagnoses:
* Ischemic cardiomyopathy
* Non-ischemic cardiomyopathy
* Non-structural heart disease
* Congenital heart disease (with a limitation to CCTGA and situs inversus)
Or: a subject must be ≥ 18 years old and have a structurally normal heart with a clinical indication for a cardiac CT.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* A known strong reaction against electrode attachment or contrast agent.
* Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
* Pregnancy, nursing or planning to be pregnant.
* The subject has an estimated glomerular filtration rate (eGFR) of \<30mL/min/1.73m2, using the MDRD calculation 14.
* Being unable to give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04548804
Study Brief:
Protocol Section:
NCT04548804