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.
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…
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