[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621443":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":18,"enrollmentInfo":62,"targetDuration":18,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm","EXPERIMENTAL","Receiving intravenous iron therapy (ferric carboxymaltose) after TAVI, administered in 1-3 settings over the course of 12 weeks.",[13],"Drug: Intravenous ferric carboxymaltose",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","NO_INTERVENTION","Receiving standard of care, i.e. no intravenous iron therapy (ferric carboxymaltose) after TAVI.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"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):\n\n1. Setting-1: After successful TAVI and before hospital discharge, a maximum of 1000 milligrams of FCM will be administered.\n2. 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.\n3. Setting-3: A third dose of 500 milligrams of FCM will be administered at week 12 if ID recurs or persists during follow-up.\n\nEach 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.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Rutger-Jan Nuis, MD, PhD","CONTACT","+31614858291","r.nuis@erasmusmc.nl",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Erasmus University Medical Center","RECRUITING","Rotterdam","South Holland","3015 GD","Netherlands","NL",{"type":41,"coordinates":42},"Point",[43,44],4.47917,51.9225,{"lat":44,"lon":43},[47],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Rutger-Jan Nuis","MD, PhD","100621443","phase-4-iron-infusion-in-patients-undergoing-transcatheter-aortic-valve-implantation-100621443",false,"NCT07370688","Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation","Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation: Study Protocol of the Randomized Controlled IRON-TAVI Trial","IRON TAVI","Inclusion Criteria:\n\n* Patient age ≥ 65 years\n* Patients with severe AS and ID undergoing successful TAVI\n* ID defined as Ferritin \\\u003C 100 ug\u002FL and\u002For Transferrin saturation \\\u003C 20%\n* Ability to perform assessment of QoL (questionnaire assessment) and EC (6-MWT)\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Contra-indication for TAVI\n* Ferritin \\> 400 ug\u002FL\n* Hemoglobin \\\u003C5.6 mmol\u002FL or \\\u003C9 g\u002FdL\n* Hemoglobin \\>8.7 mmol\u002FL or \\>14 g\u002FdL in men and \\>8.1 mmol\u002FL or \\>13 g\u002FdL in women\n* Anaemia due to known reasons other than ID and\u002For anticipated non-response to iron-supplementation (e.g. hemogobinopathy, bone marow disease, active cancer, unresolved active bleeding)\n* Chronic liver disease (including active hepatitis) and\u002For screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range.\n* Renal dialysis (previous, current, or planned within the next 6 months) or MDRD\u002FCKD-EPI estimated glomerular filtration rate \\\u003C15 mL\u002Fmin.\n* History of iron overload\n* History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 3 months and\u002For such therapy planned within next 6 months\n* Clinically apparent infection requiring antibiotic treatment\n* Known hypersensitivity to iFCM or to any of its excipients\n* Pregnancy\n* Study subject participation in another TAVI related clinical study in which the primary endpoint includes mortality, hospitalization for heart failure and\u002For quality of life assessment.","ALL","65 Years",{"count":63,"type":64},402,"ESTIMATED","INTERVENTIONAL",[67],"PHASE4","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).\n\nThe main questions it aims to answer are:\n\n1. Does intravenous iron therapy improve HRQOL after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)?\n2. 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)?\n\nThe intervention group (receiving iron therapy after TAVI) will be compared to the control group (receiving no iron therapy after TAVI (standard of care)).\n\nParticipants will:\n\n* Provide written informed consent\n* Be randomly assigned to one of two groups:\n\n  1. Intervention group: receiving intravenous iron therapy after TAVI (1-3 administrations in the course of 12 weeks)\n  2. Control group: receiving standard of care (= no iron therapy)\n* Complete assessments of HRQOL and the 6-minute walk test at baseline and week 24 after TAVI.\n* During follow-up visits, other clinical parameters will be collected (i.e. laboratory status, mortality status, adverse clinical events)",[70,71,72,73],"Aortic Valve Stenosis","Iron Deficiency","TAVI(Transcatheter Aortic Valve Implantation)","Cardiovascular Diseases",[75,76,77,70,78,79,80,71,73],"Health-related Quality of Life","Six-Minute Walk Test","Randomized Controlled Trial","Intravenous Iron Therapy","Kansas City Cardiomyopathy Questionnaire","Functional Recovery","2026-01-18",{"date":83,"type":84},"2026-01-27","ACTUAL",{"date":86,"type":84},"2024-08-12",{"date":88,"type":64},"2028-07",{"name":5,"class":6},1]