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Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation

NCT07370688 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2026-01-27

No results posted yet for this study

Summary

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 therapy improve HRQOL after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)?
2. Can intravenous iron therapy enhance exercise capacity, as measured by the 6-minute walk test, after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)?

The intervention group (receiving iron therapy after TAVI) will be compared to the control group (receiving no iron therapy after TAVI (standard of care)).

Participants will:

* Provide written informed consent
* Be randomly assigned to one of two groups:

1. Intervention group: receiving intravenous iron therapy after TAVI (1-3 administrations in the course of 12 weeks)
2. Control group: receiving standard of care (= no iron therapy)
* Complete assessments of HRQOL and the 6-minute walk test at baseline and week 24 after TAVI.
* During follow-up visits, other clinical parameters will be collected (i.e. laboratory status, mortality status, adverse clinical events)

Conditions

Interventions

DRUG

Intravenous ferric carboxymaltose

The intervention involves the administration of intravenous ferric carboxymaltose (FCM) to correct iron deficiency (ID) in patients with severe aortic stenosis. FCM will be delivered in 1 to 3 settings, depending on the patient's baseline hemoglobin level, body weight, and persistence of ID after the initial administration(s): 1. Setting-1: After successful TAVI and before hospital discharge, a maximum of 1000 milligrams of FCM will be administered. 2. Setting-2: A second dose of 500-1000 milligrams FCM will be administered during outpatient-clinic visit if the cumulative iron dosage has not yet been met. 3. Setting-3: A third dose of 500 milligrams of FCM will be administered at week 12 if ID recurs or persists during follow-up. Each dose will be infused using peripheral venous access over at least 15 minutes. The total duration of the intervention is 12 weeks, after which an endpoint outpatient follow-up assessment takes place at week 24 post-TAVI.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07370688 on ClinicalTrials.gov