[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"trans-catheter-aortic-valve-implantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:trans-catheter-aortic-valve-implantation":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100631876","comparative-observational-study-of-supra-annular-versus-intra-annular-self-expanding-aortic-valves-in-routine-clinical-practice-100631876",false,"NCT07506382","Comparative Observational Study of Supra-annular Versus Intra-annular Self-expanding Aortic Valves in Routine Clinical Practice","NEOVALVE","Inclusion Criteria:\n\n* all patients elligible for TAVR witn a self expandable device\n\nExclusion Criteria:\n\n* femoral access not suitable\n* valve in valve procedures","ALL","18 Years",{"count":19,"type":20},419,"ESTIMATED","36 Months","OBSERVATIONAL","We proposed to compare in an observational study procedural success at one month (VARC 3 criteria) and clinical and echographic follow-up at 6 months between 2 self expandable devices in TAVR : the supra annular Evolut device (Medtronic) vs the intra anular NAVITOR device (Abott)",[25],"Trans-catheter Aortic Valve Implantation",[27,28,29,30,31],"self expandable devices","intra annular design","supra annular design","procedural success","hemodynamics","RECRUITING","2026-03-26",{"date":35,"type":36},"2026-04-01","ACTUAL",{"date":38,"type":36},"2026-02-10",{"date":40,"type":20},"2028-03",{"name":42,"class":43},"University Hospital, Montpellier","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":56,"studyType":22,"phases":4,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100616701","pre-emptive-lava-ecmo-for-complex-high-risk-tavr-100616701","NCT07309029","Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR","PROspective Evaluation of Pre-empTive Left Atrial Venoarterial Extra-Corporeal Membrane oxygenaTion for Complex High-risk Transcatheter Aortic Valve Replacement: PROTECT-TAVR","PROTECT-TAVR","Inclusion Criteria:\n\n\\- Patients are required to have either a Class III hemodynamic status OR type B or type C anatomical complexity with Class II (at risk) hemodynamics (Figure 2).\n\n* Hemodynamic Criteria\n\n  * Major Criteria (Class III)\n\n    * Systolic blood pressure \\\u003C90 mmHg or MAP\\\u003C60 mmHg\n    * Need for vasopressors or inotropes to maintain MAP\\>60 mmHg\n    * Evidence of end-organ damage including: acute kidney injury, liver dysfunction, elevated lactate or altered mentation\n  * Minor Criteria (Class II)\n\n    * Left ventricular ejection fraction \\\u003C35%\n    * Pulmonary hypertension (pulmonary artery systolic pressure \\>60 mmHg) with right ventricular dysfunction\n    * Pulmonary capillary wedge pressure \\>30 mmHg\n* Anatomic criteria\n\n  * Major Criteria (Type C)\n\n    * Native or valve-in-valve TAVR requiring single-leaflet modification for a large area of myocardium at risk (e.g. patients with large or dominant left circulation)\n    * Native or valve-in-valve TAVR requiring dual-leaflet modification\n    * Severe bioprosthetic aortic regurgitation\n    * Severe 3-vessel coronary artery disease not amenable to revascularization (SYNTAX score \\>33)\n  * Minor Criteria (Type B)\n\n    * Native or valve-in-valve TAVR requiring single-leaflet modification\n    * Severe commissural misalignment requiring leaflet modification\n    * High-risk for coronary occlusion not amenable to leaflet modification\n    * Critical low-flow low-gradient aortic stenosis (defined as an estimated aortic valve area ≤0.5 cm2)\n\nExclusion Criteria:\n\n* Age \\\u003C18 or pregnant\n\n  * General absolute contraindications to TAVR\n  * Severe peripheral artery disease with infeasibility for veno-arterial extracorporeal membrane oxygenation implantation.\n  * Contraindications to transeptal cannulation (e.g. pre-existing interatrial septum occluder device).\n  * Pre-existing Impella treatment.\n  * Onset of shock \\>12 hours.\n  * Preceding cardiac arrest with prolonged resuscitation (\\>40 minutes).\n  * Other severe concomitant disease with life expectancy \\\u003C6 months.\n  * Participation in another trial with an intervention.\n  * Any class I hemodynamic status\n  * Type A anatomical complexity with class I or II hemodynamic status","100 Years",{"count":55,"type":20},30,"30 Days","The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk transcatheter aortic valve replacement (TAVR). These patients include adults with severe aortic stenosis who are hemodynamically unstable or at risk of instability due to anatomical complexity. The main questions it aims to answer are:\n\n1. Does pre-emptive LAVA-ECMO reduce the incidence of in-hospital death, intraprocedural cardiac arrest, or emergent cardiac surgery?\n2. What are the safety outcomes related to LAVA-ECMO, including major vascular, bleeding, or cardiac structural complications? -This is a single-arm, prospective, multi-center study with no comparison group.\n\nParticipants will:\n\n* Be screened for eligibility based on hemodynamic status and anatomical complexity\n* Undergo pre-emptive LAVA-ECMO cannulation prior to or during TAVR\n* Receive follow-up assessments at 30 days and 1 year, including clinical evaluation and echocardiography",[59,60,61,25],"Severe Aortic Stenosis","Cardiogenic Shock","Cardiogenic Shock, ECMO",[63,64,65],"severe aortic stenosis","cardiogenic shock","TAVR","2025-12-15",{"date":68,"type":36},"2025-12-30",{"date":70,"type":20},"2026-01-01",{"date":72,"type":20},"2027-06-30",{"name":74,"class":43},"Atlantic Health System",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100609677","optimization-of-commissural-alignment-during-transcatheter-aortic-valve-implantation-with-evolut-fx-100609677","NCT07217691","Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+","Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+. A Randomized, Prospective Study.","ALIGN-EFX","Inclusion Criteria:\n\n* Patients with severe aortic stenosis indicated for TAVI after heart team meeting.\n* Age ≥65 years.\n* Patients planned by the TAVI team to receive a self-expandable valve (Evolut FX+ valve).\n* Patients providing informed consent.\n\nExclusion Criteria:\n\n* Severe peripheral vascular disease preventing transfemoral access.\n* Prior aortic valve replacement or bicuspid valve.\n* Severely reduced kidney function (estimated glomerular filtration rate \\\u003C30).",{"count":85,"type":20},40,"INTERVENTIONAL",[88],"NA","Purpose of the Study The purpose of this study is to investigate how a transcatheter aortic valve (TAVI, biological valve prosthesis) can best be positioned in order to avoid blockage of the coronary arteries by the valve material after implantation.\n\nMethod The study will include patients undergoing TAVI. Participants will be randomized, meaning that it will be determined by chance which of two established implantation techniques is used. Both techniques are already part of routine clinical practice.\n\nExaminations After the procedure, a CT scan will be performed to evaluate the position of the valve in relation to the coronary arteries. This CT scan is the only additional examination beyond today's standard clinical practice.\n\nSignificance If one of the techniques proves to provide better positioning of the valve, this method may be recommended as standard practice in future treatment. The study will therefore contribute to improved patient safety and treatment quality, as well as increase knowledge about optimal positioning and implantation techniques in TAVI.",[91,25,92],"Aortic Stenosis","Commissural Alignment",[94,95],"TAVI","Commissural alignment","NOT_YET_RECRUITING","2025-10-14",{"date":99,"type":36},"2025-10-16",{"date":101,"type":20},"2025-11-01",{"date":103,"type":20},"2026-05-01",{"name":105,"class":43},"Oslo University Hospital"]