Actively Recruiting
Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation
Led by Erasmus Medical Center · Updated on 2026-01-27
402
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of the open-label, randomized controlled superiority IRON TAVI trial is to investigate whether intravenous iron therapy (ferric carboxymaltose) improves Health-Related Quality of Life (HRQOL) in patients with severe aortic stenosis (AS) and iron deficiency (ID), undergoing transcatheter aortic valve implantation (TAVI). The main questions it aims to answer are: 1. Does intravenous iron therapy improve HRQOL after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)? 2. Can intravenous iron therapy enhance exercise capacity, as measured by the 6-minute walk test, after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)? The intervention group (receiving iron therapy after TAVI) will be compared to the control group (receiving no iron therapy after TAVI (standard of care)). Participants will: * Provide written informed consent * Be randomly assigned to one of two groups: 1. Intervention group: receiving intravenous iron therapy after TAVI (1-3 administrations in the course of 12 weeks) 2. Control group: receiving standard of care (= no iron therapy) * Complete assessments of HRQOL and the 6-minute walk test at baseline and week 24 after TAVI. * During follow-up visits, other clinical parameters will be collected (i.e. laboratory status, mortality status, adverse clinical events)
CONDITIONS
Official Title
Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age 65 years
- Patients with severe aortic stenosis and iron deficiency undergoing successful TAVI
- Iron deficiency defined as Ferritin < 100 ug/L and/or Transferrin saturation < 20%
- Ability to perform quality of life questionnaire and 6-minute walk test
- Signed informed consent
You will not qualify if you...
- Contraindication for TAVI
- Ferritin > 400 ug/L
- Hemoglobin < 5.6 mmol/L or < 9 g/dL
- Hemoglobin > 8.7 mmol/L or > 14 g/dL in men and > 8.1 mmol/L or > 13 g/dL in women
- Anemia due to known causes other than iron deficiency or expected non-response to iron therapy
- Chronic liver disease or elevated liver enzymes above three times normal
- Renal dialysis or estimated glomerular filtration rate < 15 mL/min
- History of iron overload
- Recent or planned erythropoietin, iron therapy, or blood transfusion within specified timeframes
- Active infection requiring antibiotics
- Known hypersensitivity to intravenous ferric carboxymaltose or its components
- Pregnancy
- Participation in another TAVI clinical study involving mortality, heart failure hospitalization, or quality of life endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
R
Rutger-Jan Nuis, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here