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Iron Infusion in Elderly Patients undergoing Transcatheter Aortic Valve Implantation (IRON TAVI) Trial
EU CTIS ID: 2023-505095-29-03
What this study is testing
To determine whether intravenous iron (ferric carboxymaltose) would improve Quality of life and Exercise Capacity in patients with severe Aortic Stenosis and Iron Deficiency undergoing TAVI
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 assessment of quality of life (questionnaire assessment), exercise capacity (6-minute walk test) and cognitive function assessment (questionnaire assessment).
- Signed Informed Consent
You likely can't join if
- Contra-indication for transfemoral TAVI
- Clinically apparent infection requiring antibiotic treatment
- Known hypersensitivity to iFCM or to any of its excipients
- Pregnancy
- Study subject participation in another TAVI related clinical study in which the primary endpoint includes mortality, hospitalization for heart failure and/or quality of life assessment.
- Ferritin > 400 ug/L
See the full eligibility criteria
- 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 assessment of quality of life (questionnaire assessment), exercise capacity (6-minute walk test) and cognitive function assessment (questionnaire assessment).
- Signed Informed Consent
- Contra-indication for transfemoral TAVI
- Clinically apparent infection requiring antibiotic treatment
- Known hypersensitivity to iFCM or to any of its excipients
- Pregnancy
- Study subject participation in another TAVI related clinical study in which the primary endpoint includes mortality, hospitalization for heart failure and/or quality of life assessment.
- 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
- Anaemia due to known reasons other than ID and/or anticipated non-response to iron-supplementation (e.g. hemogobinopathy, bone marow disease, active cancer, unresolved active bleeding)
- Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range.
- Renal dialysis (previous, current, or planned within the next 6 months) or MDRD/CKD-EPI estimated glomerular filtration rate <15 mL/min.
- History of iron overload
- History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 3 months and/or such therapy planned within next 6 months
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.