Actively Recruiting
Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation: Study Protocol of the Randomized Controlled IRON-TAVI Trial
Led by Erasmus Medical Center · Updated on 2026-01-27
402
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving intravenous iron therapy (ferric carboxymaltose) improves the quality of life and exercise capacity in patients aged 65 and older with severe aortic valve stenosis and iron deficiency who are undergoing transcatheter aortic valve implantation (TAVI). This Phase 4 randomized controlled trial compares patients receiving iron therapy after TAVI with those receiving standard care without iron therapy. The study is sponsored by Erasmus Medical Center. Participants in the intervention group receive intravenous iron therapy in one to three doses over 12 weeks, depending on their iron levels and response. The first dose is given after successful TAVI before hospital discharge, with possible additional doses at outpatient visits if iron deficiency persists. The control group receives no intravenous iron therapy and follows standard care. The total intervention period lasts 12 weeks, followed by further assessments. Throughout the study, participants complete quality of life questionnaires and perform a 6-minute walk test before TAVI and again 24 weeks after TAVI. Other clinical data, including laboratory tests, mortality status, and adverse events, are collected during follow-up visits. Secondary measures include cognitive function, heart failure symptoms, overall health status, and mortality. The study aims to monitor safety and treatment effects up to 24 weeks post-TAVI.
CONDITIONS
Brief Title
Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age 65 years or older
- Patients with severe aortic valve stenosis and iron deficiency undergoing successful TAVI
- Iron deficiency defined as ferritin less than 100 ug/L and/or transferrin saturation less than 20%
- Ability to perform quality of life questionnaires and 6-minute walk test
- Signed informed consent
You will not qualify if you...
- Contraindication for TAVI
- Ferritin greater than 400 ug/L
- Hemoglobin less than 5.6 mmol/L or less than 9 g/dL
- Hemoglobin greater than 8.7 mmol/L or greater than 14 g/dL in men and greater than 8.1 mmol/L or greater than 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 less than 15 mL/min
- History of iron overload
- Iron therapy, erythropoietin, or blood transfusion within past 3 months or planned within next 6 months
- Active infection needing antibiotics
- Known allergy to intravenous ferric carboxymaltose or its ingredients
- Pregnancy
- Participation in another TAVI clinical study with similar primary endpoints
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive intravenous ferric carboxymaltose to correct iron deficiency in 1 to 3 settings after Transcatheter Aortic Valve Implantation (TAVI). The first dose is administered after successful TAVI and before hospital discharge. Additional doses may be given during outpatient visits up to 12 weeks.
1 to 3 infusions depending on iron levels and follow-up visits for assessment
Duration - 12 weeks after treatment ends
Participants undergo an outpatient follow-up assessment 24 weeks post-TAVI to evaluate health-related quality of life, physical function, cognitive function, and other health outcomes.
1 outpatient visit (in-person) at week 24 post-TAVI
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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