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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT03347851
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects 18-89 years of age
* Patients with aortic valve disease who within the last five years underwent AVR using the On-X aortic valve, SJM Masters HP, or Carbomedics aortic valves.
Exclusion Criteria:
* Patients contraindicated against MRI
* Patients with pacemakers, cochlear (in the ear) implants, or aneurysm clips or patients who have worked with metal
* Patients unwilling or unable to give written informed consent
* Pregnant women
* Prisoners
* Patients with an Effective Orifice Area index (EOAi) \<0.85 cm2/m2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT03347851
Study Brief:
Protocol Section:
NCT03347851