[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-stenosis-senile\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-stenosis-senile":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100655008","safety-and-clinical-performance-of-the-next-generation-safesync-transcatheter-heart-valve-in-patients-with-severe-aortic-stenosis-100655008",false,"NCT07806409","Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis","Evaluation of the Safety and Clinical Performance of the Next-Generation SAFESYNC Balloon-Expandable Transcatheter Heart Valve in Patients With Severe Aortic Stenosis: A Prospective, Multicenter, Single-Arm Pivotal Study","SAFESYNC NG","Inclusion Criteria:\n\n* Severe aortic valve stenosis diagnosed according to criteria established in current guidelines.\n* Intermediate or higher surgical risk, defined as a Society of Thoracic Surgeons (STS) score ≥4%.\n* Indication for transcatheter aortic valve implantation (TAVI).\n* Willing and able to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Any condition considered a contraindication to implantation of a bioprosthetic heart valve (e.g., indication for a mechanical heart valve).\n* Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, nitinol (titanium or nickel), or contrast media that cannot be adequately managed with premedication. This includes heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia with thrombosis (HITTS).\n* Blood dyscrasias, including leukopenia (white blood cell count \\\u003C1,000\u002Fmm³), thrombocytopenia (platelet count \\\u003C100,000 cells\u002Fmm³), history of coagulopathy, or hypercoagulable states.\n* Active infection, including endocarditis.\n* Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or requirement for mechanical hemodynamic support.\n* Stroke or transient ischemic attack (TIA) within 2 months prior to the index procedure.\n* History of gastrointestinal bleeding or other bleeding that precludes anticoagulant or antiplatelet therapy.\n* Estimated life expectancy of less than 24 months.\n* Other medical, social, or psychological conditions that, in the investigator's opinion, may prevent the participant from providing informed consent or adequately complying with the study protocol.\n* Pre-existing prosthetic heart valve, either biological or mechanical, in the aortic position.\n* Concomitant severe mitral or tricuspid valve disease.\n* Hypertrophic obstructive cardiomyopathy.\n* Successful percutaneous coronary intervention (PCI) performed within 48 hours prior to TAVI.\n* Femoral artery diameter \\\u003C5.5 mm for SAFESYNC 20-24 mm, \\\u003C6.0 mm for SAFESYNC 26-28 mm, or \\\u003C6.5 mm for SAFESYNC 30 mm.\n* High risk of aortic annular rupture or significant residual paravalvular leak due to severe calcification of the aortic valve or left ventricular outflow tract.\n* High risk of coronary obstruction, defined by computed tomography angiography as coronary ostial height \\\u003C10 mm with narrow sinuses of Valsalva (SOV), with a mean SOV diameter \\\u003C3 mm greater than the bioprosthetic valve size.\n* Left ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤30%.\n* Severe chronic kidney disease, defined as glomerular filtration rate (GFR) \\\u003C30 mL\u002Fmin\u002F1.73 m².","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE® SAFESYNC Bioprosthetic Heart Valve, implanted via a transcatheter approach, in patients with severe aortic stenosis, an indication for TAVI, and intermediate or higher surgical risk. The study will enroll 40 participants.",[27,28,29],"Aortic Stenosis Senile","Aortic Stenosis Symptomatic","Aortic Stenosis",[31,32,33,34],"Aortic Valve Stenosis","Transcatheter Aortic Valve Implantation","TAVI","Balloon-Expandable Transcatheter Heart Valve","NOT_YET_RECRUITING","2026-09-03",{"date":38,"type":39},"2026-09-08","ACTUAL",{"date":41,"type":21},"2026-11",{"date":43,"type":21},"2032-06",{"name":45,"class":46},"Braile Biomedica Ind. Com. e Repr. Ltda.","INDUSTRY"]