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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT06047561
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged \>50 years
* Provision of informed consent prior to any study specific procedures
* Patients with bioprosthetic aortic valve replacements, including both surgically and transcatheter implanted valves
* Patients with severe aortic stenosis (peak velocity \>4.0 m/s; previously recruited patients)
* Patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s; new prospectively recruited patients)
* Patients with mild aortic stenosis (peak velocity 2.5-2.9 m/s; new prospectively recruited patients)
* Patients with aortic sclerosis (tri-leaflet thickened aortic valve with no obstruction of ventricular outflow)
* Age and sex-matched healthy volunteers
Exclusion Criteria:
* Inability or unwilling to give informed consent.
* Those with an allergy to iodinated contrast
* Patients with impaired renal function (eGFR of \<30 mL/min/1.73m2)
* Women who are pregnant or breastfeeding.
* Patients with known Rheumatic Heart Disease
* Patients with known Ochronosis
* Patients with known Familial Homozygous Hypercholesterolaemia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06047561
Study Brief:
Protocol Section:
NCT06047561