[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medtronic Cardiovascular\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":208},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,40,68,91,117,145,177],{"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":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100395743","ttvr-early-feasibility-study-100395743",false,"NCT04433065","TTVR Early Feasibility Study","The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System","Inclusion Criteria:\n\n* Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement\n* Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team\n* Subjects with severe symptomatic primary and \u002F or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)\n* New York Heart Association (NYHA) Function Class II or greater\n* Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access\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* Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions\n* Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)\n* Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus\n* Implanted with venous stents (iliac and\u002For femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system\n* Echocardiographic evidence of severe right ventricular dysfunction\n* Left ventricular ejection fraction (LVEF) \\\u003C30 as measured by resting echocardiogram within 30 days of the Index Procedure\n* Need for emergent or urgent surgery\n* Untreated clinically significant coronary artery disease requiring revascularization\n* Carcinoid tricuspid regurgitation","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.",[26],"Tricuspid Regurgitation","RECRUITING","2026-06-26",{"date":30,"type":31},"2026-06-29","ACTUAL",{"date":33,"type":31},"2020-10-20",{"date":35,"type":20},"2031-07-30",{"name":37,"class":38},"Medtronic Cardiovascular","INDUSTRY",20,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100304396","transcatheter-mitral-valve-replacement-with-the-medtronic-intrepid-tmvr-system-in-patients-with-severe-symptomatic-mitral-regurgitation-100304396","NCT03242642","Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.","Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial","APOLLO","Inclusion Criteria:\n\n* Moderate to severe or severe symptomatic mitral regurgitation\n* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention\n\nExclusion Criteria:\n\n* prior transcatheter mitral valve procedure with device currently implanted\n* anatomic contraindications\n* prohibitive mitral annular calcification\n* left ventricular ejection fraction \\\u003C25%\n* need for emergent or urgent surgery\n* hemodynamic instability",{"count":49,"type":20},1056,[23],"Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.",[53],"Mitral Valve Regurgitation",[55,56,57,58,59,60],"Heart disease","valve disease","heart valve disease","mitral regurgitation","cardiovascular disease","mitral insufficiency",{"date":30,"type":31},{"date":63,"type":31},"2017-10-23",{"date":65,"type":20},"2036-09-30",{"name":37,"class":38},85,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100575829","redo-transcatheter-aortic-valve-replacement-for-transcatheter-aortic-valve-failure-100575829","NCT06777368","REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE","RESTORE","Inclusion Criteria:\n\n* BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR\n\nExclusion Criteria:\n\n* BVF due solely to paravalvular regurgitation\n* Active endocarditis\n* Untreated acute valve thrombosis\n* Life-expectancy less than 1-year\n* Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable\n* Participating in another study that may influence the outcome of this study","105 Years",{"count":77,"type":20},225,"OBSERVATIONAL","The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).",[81],"Aortic Stenosis","2026-05-27",{"date":84,"type":31},"2026-05-28",{"date":86,"type":31},"2025-02-06",{"date":88,"type":20},"2027-11",{"name":37,"class":38},71,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100585788","harmony-tpv-emea-pms-100585788","NCT06906926","Harmony TPV EMEA PMS","Harmony TPV EMEA Post-Market Study","Inclusion Criteria:\n\n1. Subject eligible to receive Harmony TPV System in conformity with Instructions for Use (IFU) and local regulations at time of study enrollment.\n2. Subject or subject's parent(s)\u002Flegal guardian(s) must be willing and able to consent to participate in the study and will commit to completion of all follow-up requirements\n\nExclusion Criteria:\n\n1. Obstruction of the central veins.\n2. Planned concomitant branch pulmonary artery stenting at time of implant.\n3. Subjects previously treated with an RV-PA conduit or previously implanted bioprosthesis.\n4. A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year.\n5. Planned implantation of the Harmony TPV in the left heart.\n6. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n7. Pre-existing prosthetic heart valve or prosthetic ring in any position\n8. Subject is pregnant as confirmed by a positive pregnancy test before implant procedure for female subjects of childbearing potential.\n9. Subjects that are vulnerable as defined in the Section 10.5 Subject Consent\n\nSubject Consent Section excerpt:\n\n* Vulnerable adults, defined as subjects incapable of giving consent, as assessed per Investigator's opinion and in consideration of vulnerable adult definition per ISO 14155, will not be included in this study.\n* Any subject with mental incompetence (e.g. Alzheimer's, dementia, psychiatric disorders, developmental disorders, chromosomal abnormalities with associated cognitive impairment) should be assessed by the Investigator for vulnerable status. If pediatric or adult subject is deemed by the Investigator mentally incompetent as described above, the subject will not be included in this study.",{"count":99,"type":20},80,[23],"The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and\u002For pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement as judged by the medical team.",[103],"Severe Pulmonary Valve Regurgitation",[105,106,107],"Harmony TPV","severe pulmonary regurgitation","pulmonary valve replacement","2026-05-04",{"date":110,"type":31},"2026-05-05",{"date":112,"type":31},"2025-07-30",{"date":114,"type":20},"2032-12-31",{"name":37,"class":38},12,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":125,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100468328","endurant-stent-graft-system-vs-excluder-endoprothesis-advance-trial-100468328","NCT05378347","Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial","Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression","ADVANCE","Inclusion Criteria:\n\n* Subject and the treating physician agree that the subject will return for all required follow up visits\n* Subject or legal representative or consultee, as applicable, has consented for trial participation and signed the Informed Consent approved by the sponsor and by the Ethics Committee\u002FInstitutional Review Board\n* Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda.\n* Subject's AAA anatomy is appropriate for both Medtronic Endurant II\u002FIIs Stent Graft System and Gore Excluder\u002FExcluder Conformable AAA Endoprosthesis as per assessment of both treating physician and Core Lab in accordance with the overlapping commercially available IFUs per applicable region.\n\nExclusion Criteria:\n\n* Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial\n* Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator\n* Subject has an aneurysm that is:\n\n  1. Suprarenal\u002Fpararenal\u002Fjuxtarenal\n  2. Isolated ilio-femoral\n  3. Mycotic\n  4. Inflammatory\n  5. Pseudoaneurysm\n  6. Concomitant or prior dissection involving the abdominal aorta or iliac arteries\n  7. Ruptured\n  8. Symptomatic AAA\n* Subject has significant thrombus and \u002F or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Significant thrombus may be quantified as thrombus ≥ 2 mm in thickness and \u002F or ≥ 25% of the vessel circumference in the intended seal zone of the aortic neck.\n* Subject requires emergent aneurysm treatment, for example, trauma or rupture\n* Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome\n* Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease\n* Planned use of aorto-uni-iliac (AUI) main body device\n* Any planned additional device (apart from the main body, limb stent graft and extensions per assigned treatment per randomization) during index or staged procedure, e.g., endostaple or anchor, Iliac branch endoprosthesis, embolization, etc.\n* Planned coverage of the internal iliac artery\u002Farteries\n* Subject has an estimated glomerular filtration rate (eGFR) \\\u003C 45 ml\u002Fmin\u002F1.73m2 or subject is on dialysis\n* Subject has a systemic infection who may be at increased risk of endovascular graft infection, per investigator's discretion\n* Subject has a psychiatric or other condition that may interfere with the trial, per investigator's discretion\n* Subject is of childbearing potential in whom pregnancy cannot be excluded\n* Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment\n* Subject belongs to a vulnerable population per investigator's judgment\n* Subject has an active COVID-19 infection or relevant history of COVID- 19","20 Years",{"count":127,"type":20},600,[23],"The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II\u002FIIs Stent Graft Systems verses Gore Excluder \u002F Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.",[131,132,133],"Abdominal Aortic Aneurysm","Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)","Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)",[135],"EVAR, AAA","2026-04-02",{"date":138,"type":31},"2026-04-08",{"date":140,"type":31},"2023-01-05",{"date":142,"type":20},"2031-05",{"name":37,"class":38},68,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":168,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":4},"100617690","transcatheter-tricuspid-valve-replacement-with-the-medtronic-intrepid-transcatheter-tricuspid-valve-replacement-ttvr-system-in-severe-tricuspid-regurgitation-100617690","NCT07321899","Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation","Transcatheter Tricuspid Valve Replacement Using the Medtronic Intrepid™ TTVR System in Patients With Severe Symptomatic Tricuspid Regurgitation - PATHFINDER","PATHFINDER","Inclusion Criteria:\n\n* Age ≥18 years at the time of consent.\n* Severe symptomatic tricuspid regurgitation (TR) despite optimal medical therapy (OMT).\n* Local site multidisciplinary heart team experienced in tricuspid valve therapies agrees that the subject is appropriate for TTVR.\n\nExclusion Criteria:\n\n* Any tricuspid device currently in place.\n* Anatomic contraindications.\n* Need for emergent or urgent surgery.\n* Left ventricular ejection fraction \\\u003C25%.",{"count":154,"type":20},1186,[23],"This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.",[158],"Severe Tricuspid Regurgitation",[26,160,161,162,163,164,165,166,167],"Symptomatic tricuspid regurgitation","Heart valve disease","Structural heart intervention","Severe valve disease","Randomized controlled trial","tricuspid insufficiency","tricuspid disease","tricuspid valve disease","NOT_YET_RECRUITING","2026-01-06",{"date":171,"type":31},"2026-01-08",{"date":173,"type":20},"2026-06",{"date":175,"type":20},"2041-04",{"name":37,"class":38},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},"100477440","transcatheter-mitral-valve-replacement-in-patients-with-severe-symptomatic-mitral-regurgitation---apollo-eu-trial-100477440","NCT05496998","Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial","Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial","APOLLO-EU","Inclusion Criteria:\n\n* Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC\n* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery\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* Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System\n\nExclusion Criteria:\n\n* Estimated life expectancy of less than 24 months\n* Currently surgically implanted mitral valve\n* Prior transcatheter mitral valve procedure with device currently implanted\n* Anatomic contraindications\n* Anatomically prohibitive mitral annular calcification (MAC)\n* Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment\n* LVEF \\\u003C 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - \\\u003C30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)\n* Left ventricular end diastolic diameter (LVEDD) \\> 75mm\n* Need for emergent or urgent surgery\n* Hemodynamic instability\n* History of bleeding diathesis or coagulopathy\n* End stage renal disease\n* Liver failure\n* Frailty",{"count":186,"type":20},400,[23],"Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.",[190],"Mitral Regurgitation",[192,193,194,195,196,197,198],"mitral","valve","regurgitation","TMVR","Intrepid™","symptomatic","severe","2025-12-12",{"date":201,"type":31},"2025-12-17",{"date":203,"type":31},"2023-02-07",{"date":205,"type":20},"2038-12",{"name":37,"class":38},37,""]