Study of Intravenous Iron Therapy to Improve Quality of Life After Transcatheter Aortic Valve Implantation in Patients Aged 65 and Older with Severe Aortic Stenosis and Iron Deficiency

What this Trial Is About

Researchers are evaluating whether giving intravenous iron therapy ferric carboxymaltose improves the quality of life and exercise capacity in patients aged 65 and older with severe aortic valve stenosis and iron deficiency who are undergoing transcatheter aortic valve implantation TAVI. This Phase 4 randomized controlled trial compares patients receiving iron therapy after TAVI with those receiving standard care without iron therapy. The study is sponsored by Erasmus Medical Center. Participants in the intervention group receive intravenous iron therapy in one to three doses over 12 weeks, depending on their iron levels and response. The first dose is given after successful TAVI before hospital discharge, with possible additional doses at outpatient visits if iron deficiency persists. The control group receives no intravenous iron therapy and follows standard care. The total intervention period lasts 12 weeks, followed by further assessments. Throughout the study, participants complete quality of life questionnaires and perform a 6-minute walk test before TAVI and again 24 weeks after TAVI. Other clinical data, including laboratory tests, mortality status, and adverse events, are collected during follow-up visits. Secondary measures include cognitive function, heart failure symptoms, overall health status, and mortality. The study aims to monitor safety and treatment effects up to 24 weeks post-TAVI.

Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation