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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT04786769
Eligibility Criteria:
Inclusion Criteria:
* Severe aortic stenosis
* Enrolled for TAVI or SAVR procedures
* Documented iron deficiency with either: Ferritin \<100ug/L or Ferritin between 100-299ug/L and Transferrin Saturation \< 20%.
Exclusion Criteria:
* Use of packed red blood cells or whole blood in the past 3 months;
* Use of erythropoietin-stimulating agent or IV iron in the past 3 months;
* Use of oral or IV iron (\>100mg/day) in the past 3 months;
* Haemoglobin (Hb) levels \> 15g/dL or \< 8g/dL;
* Active cancer;
* Infection requiring antibiotic treatment at the time of first scheduled dose;
* Any known contraindication to study intervention
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04786769
Study Brief:
Protocol Section:
NCT04786769