Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation

Recruiting Phase 4 Interventional Study
Aortic Valve Stenosis Iron Deficiency TAVI(Transcatheter Aortic Valve Implantation) Cardiovascular Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
65 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
402 (estimated)
Sponsor
Erasmus Medical Center · Other
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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
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 Cr…
Contacts

Rutger-Jan Nuis, MD, PhD

+31614858291

r.nuis@erasmusmc.nl

CONTACT