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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT02390102
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≥60-year old
2. Symptomatic aortic stenosis with a clinical indication for transcatheter aortic valve replacement, regardless of simultaneous percutaneous coronary intervention
3. Anemia defined according to the World Health Organization (WHO) definition 69:
1. Men: Hemoglobin\<130 g/L
2. Women: \<120 g/L
Exclusion Criteria:
1. Contraindication for transcatheter aortic valve replacement.
2. Erythropoietin treatment within last 30 days before Aortic Valve Replacement
3. Known anemia due to aplasia, other hemoglobinopathy or active bleeding requiring blood transfusion within last 30 days before Aortic Valve Replacement
4. Ferritin\>800 µg/L
5. Uncontrolled hypertension (Blood pressure\>175/95 )
6. Platelet count\>450,000/L
7. Recent myocardial infarction requiring percutaneous coronary intervention or disabling stroke (within the last 30 days)
8. Dialysis patients
9. Hemodynamic instability as defined as the need of hemodynamic support with inotropic drugs, intraortic balloon pump counter-pulsation or left ventricular assist device before index procedure
10. Active cancer or very high risk of thromboembolic events
11. Known allergy or hypersensitivity to intravenous iron or Erythropoietin therapy
12. No written consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02390102
Study Brief:
Protocol Section:
NCT02390102