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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT03128268
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* with a valid prescription for Cardiac MRI for the following: Congenital heart disease/Shunts, Valvular heart disease, Pulmonary Hypertension, Aortic Disease, Hypertrophic Cardiomyopathy (HCM)
* receiving Standard of Care services at the MRI Center
* consent to participate in the 4D trial
Exclusion Criteria:
Patients with any of the following will be excluded:
* Pacemaker or ICD implanted
* ICDs implanted
* Temporary Pacemakers (e.g. transvenous temporary wires)
* Leads that are abandoned (capped or retained leads not attached to device)
* Non-transvenous leads (e.g. epicardial leads)
* Leads that have no fixation (e.g. floating leads)
* A lead that is known to be fractured
* Any other metallic objects that, in the opinion of the safety officer would compromise patient safety
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03128268
Study Brief:
Protocol Section:
NCT03128268