[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prosthesis-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prosthesis-failure":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,76,111,135],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100641087","post-market-clinical-follow-up-pmcf-study-evaluating-the-safety-and-efficacy-of-tpmed-revision-hip-prosthesis-system-100641087",false,"NCT07653295","Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System","A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System","Inclusion Criteria:\n\n* Individuals aged 18 years and older,\n* Male or female participants,\n* Participants who have undergone Revision Hip Arthroplasty (either total revision or partial component revision) for any indication (such as a documented joint failure or prosthesis-related clinical complication),\n* Participants in whose revision procedure the Tıpmed™ Revision Hip Prosthesis System components were utilized,\n* Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship),\n* Participants who have voluntarily signed the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Subjects currently participating in any other interventional clinical trial.","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","OBSERVATIONAL","This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Revision Hip Prosthesis System in adult participants undergoing revision hip arthroplasty. The study aims to gather real-world clinical evidence on the 24-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.",[24,25,26,27,28,29],"Revision Hip Arthroplasty","Aseptic Loosening of Prosthetic Joint","Prostheses-related Infections","Joint Instability","Periprosthetic Fractures","Prosthesis Failure",[31,24,32,33,34],"Hip Prosthesis","Revision Hip Prosthesis","Post-Market Clinical Follow-Up (PMCF)","Harris Hip Score (HHS)","RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":39},"2024-03-12",{"date":43,"type":20},"2029-03-31",{"name":45,"class":46},"TIPMED Medical Device Manufacturing Ltd. Co.","INDUSTRY",4,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100474540","valve-hemodynamic-optimization-based-on-doppler-echocardiography-vs-catheterization-measurements-following-viv-tavr-100474540","NCT05459233","Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR","Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial","ECHOCATH","Inclusion Criteria:\n\n* Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and\u002For regurgitation approved for a valve-in-valve procedure by the Heart Team\n* Surgical stented bioprosthetic valve (label size ≤25 mm)\n* TAVR with the SAPIEN 3 Ultra valve\n\nExclusion Criteria:\n\n* Stentless or sutureless surgical valves\n* Trifecta bioprosthesis\n* Hancock II bioprosthesis\n* High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT \\\u003C4 mm or based on the criterion of the heart team responsible for the procedure).\n* Impossibility to obtain written informed consent",{"count":57,"type":20},310,"INTERVENTIONAL",[60],"NA","Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,",[63,64,29],"Aortic Valve Stenosis","Aortic Valve Regurgitation","2026-03-23",{"date":67,"type":39},"2026-03-24",{"date":69,"type":39},"2023-01-11",{"date":71,"type":20},"2029-09-01",{"name":73,"class":74},"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval","OTHER",7,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":21,"phases":4,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":110},"100485467","the-retavi-prospective-observational-registry-100485467","NCT05601453","The ReTAVI Prospective Observational Registry","Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry","Inclusion Criteria:\n\nConsecutive patients fulfilling the following criteria:\n\n1. Consenting adult patient (≥18 years)\n2. Procedural success of the first TAVI\n3. TAVI device failure of the index THV, irrespective of SVD severity\n4. Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)\n5. The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI\n6. Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)\n\nExclusion Criteria:\n\n1. Patients without signed informed consent \u002F data protection statement (according to requirements of local IRB\u002FIEC)\n2. Life expectancy below 12 months\n3. Patients with largely incomplete data with respect to the aims of the project\n4. Pregnant women at the time of the redo-TAVI\n\nNote: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.",{"count":84,"type":20},250,"5 Years","Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \\& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure.\n\nThe evidence on redo-TAVI (where a transcatheter heart valve \\[THV\\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations.\n\nAim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year, 3 years and 5 years.",[88,89,90,91,29],"Structural Valve Deterioration","Structural Valve Degeneration","Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure","Prosthetic Valve Malfunction",[93,88,94,95,96,97,98,99],"Transcatheter Aortic Valve Implantation (TAVI)","redo-TAVI","THV-in-THV","TAV-in-TAV","TAVR-in-TAVR","Redo-TAVR","Revalve","2025-08-14",{"date":102,"type":39},"2025-08-20",{"date":104,"type":39},"2023-09-05",{"date":106,"type":20},"2031-12",{"name":108,"class":109},"Institut für Pharmakologie und Präventive Medizin","NETWORK",62,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":58,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100546851","randomized-evaluation-for-failed-tavr-100546851","NCT06400342","Randomized Evaluation for Failed TAVR","Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)","REVIVE-TAVR","Inclusion Criteria:\n\n* Heart Team has confirmed eligibility for both TAVR-explant and redo-TAVR for failed THV\n* Subject is symptomatic from their failed THV, as demonstrated by NYHA Functional Class ≥II\n* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.\n\nExclusion Criteria:\n\n* Ongoing sepsis, including active endocarditis;\n* Severe dementia (resulting in either inability to provide informed consent for the trial\u002Fprocedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);\n* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;\n* Pregnancy or intent to become pregnant for the next 12 months;\n\nCoronary obstruction risk:\n\n\\- Patients at risk of coronary obstruction may be enrolled into the randomized cohort if the operators determine that redo-TAVR can be safely accomplished with leaflet modification or other coronary protection strategies.","100 Years",{"count":121,"type":20},264,[60],"REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR. This is a prospective, multicenter, global randomized trial investigating the safety and efficacy of reintervention for transcatheter heart valve (THV) failure by comparing redo-TAVR (TAV-in-TAV) with TAVR surgical explantation (TAVR-explant) in subjects who are suitable for both options in a real-world clinical setting",[90,91,29],"NOT_YET_RECRUITING","2025-01-21",{"date":128,"type":39},"2025-01-24",{"date":130,"type":20},"2025-03-01",{"date":132,"type":20},"2036-05-01",{"name":134,"class":74},"Medstar Health Research Institute",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100415358","clinical-and-functional-outcome-of-the-mobilelink-acetabular-cup-system-in-the-short--mid--and-longterm-follow-up-100415358","NCT04688593","Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up","Inclusion Criteria:\n\n* Implantation of a MobileLink acetabular cup system and a femoral stem manufactured by Waldemar Link\n* Age ≥ 18 years\n* Fully signed patient informed cons\n\nExclusion Criteria:\n\n* Revisions\n* Body Mass Index (BMI) ≥ 40 kg\u002Fm²\n* Patient who is foreseeable not able to understand the study and the study-related circumstances\n* Patients who is foreseeable non-compliant to the treatment and the follow-ups\n* Pregnant or breast-feeding women\n* Prisoner",{"count":142,"type":20},520,"The implantation of artificial hip joints is one of the most frequently performed surgeries. Normally, patients are very satisfied with the results.\n\nThe MobileLink hip prosthesis system is a CE marked medical device. This means the the safety and performance of the prosthesis ist approved. Aim of the study is to collect clinical data about the outcome of the MobileLink hip prosthesis system under routine condition and to determine the satisfaction of the patients.",[145,146,147,29],"Osteoarthritis, Hip","Hip Osteoarthritis","Prosthesis Survival",[149],"MobileLink","2024-01-24",{"date":152,"type":39},"2024-01-25",{"date":154,"type":39},"2021-05-04",{"date":156,"type":20},"2036-01",{"name":158,"class":46},"Waldemar Link GmbH & Co. KG",2]