Intravenous iron infusion after transcatheter aortic valve implantation for people with iron deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

IRON TAVI is an open-label, randomized controlled superiority trial that compares intravenous ferric carboxymaltose given after successful TAVI to standard care with no IV iron. Eligible participants are adults aged 65 or older with severe aortic stenosis and iron deficiency who can complete quality-of-life questionnaires and a six-minute walk test. Participants are randomized after informed consent, and the study measures health-related quality of life as the primary outcome and six-minute walk distance as a key secondary outcome at predefined follow-up visits. The design tests whether correcting iron deficiency in addition to valve replacement improves symptoms and functional capacity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient age ≥ 65 years
* Patients with severe AS and ID undergoing successful TAVI
* ID defined as Ferritin \< 100 ug/L and/or Transferrin saturation \< 20%
* Ability to perform assessment of QoL (questionnaire assessment) and EC (6-MWT)
* Signed Informed Consent

Exclusion Criteria:

* Contra-indication 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
* 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
* 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.

Where it's running

• Erasmus University Medical Center
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Rutger-Jan Nuis, MD, PhD
• Email: r.nuis@erasmusmc.nl
• Phone: +31614858291

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.