[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-aortic-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-aortic-stenosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,46,70,100,128,151,173,195,222,250,278,301,323,345],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100607877","a-clinical-trial-assessing-the-safety-and-effectiveness-of-the-duravr-thv-system-100607877",false,"NCT07194265","A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System","A Prospective Randomized Trial Assessing the Safety and Effectiveness of the DurAVR® Biomimetic Valve Designed for Physiologic Flow Compared to Commercial TAVR Devices","PARADIGM","Inclusion Criteria:\n\nNative Aortic Stenosis Cohorts:\n\n1. The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.\n2. The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis.\n3. Subject understands the study requirements and the treatment procedure and provides written informed consent.\n\nViV Registry Cohort:\n\n1. Severe degeneration of a surgically implanted aortic bioprosthetic valve.\n2. Subject requires aortic valve replacement and is high surgical risk and is indicated for TAVR Valve-in-Valve procedure as determined by the Heart Team.\n3. Subject understands the study requirements and the treatment procedure and provides written informed consent.\n\nExclusion Criteria:\n\nNative Aortic Stenosis Cohorts:\n\n1. Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis.\n2. Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control).\n3. Evidence of an acute myocardial infarction 30 days before randomization.\n4. AV is unicuspid, Type 0 bicuspid, or is non-calcified.\n5. Severe total aortic regurgitation\n6. Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis.\n7. Pre-existing mechanical or bioprosthetic valve in any position.\n8. Untreated clinically significant coronary artery disease (CAD) requiring revascularization.\n9. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.\n10. Active bacterial endocarditis in the last 3 months.\n11. Estimated life expectancy (after TAVR) \\\u003C12 months.\n12. Subject is not a candidate for both arms (investigational and control) of the study.\n13. Subject belongs to a vulnerable population\n\nViV Registry Cohort:\n\n1. Anatomy precluding safe placement of DurAVR THV.\n2. Pre-existing prosthetic heart valve in the mitral, tricuspid or pulmonary position.\n3. Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis\n4. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation.\n5. Failing surgical aortic bioprosthesis is unstable, rocking, or not structurally intact.\n6. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.\n7. Untreated clinically significant coronary artery disease (CAD) requiring revascularization.\n8. Need for emergency surgery for any reason\n9. GI bleeding within the past 3 months.\n10. Active bacterial endocarditis in the last 3 months.\n11. Estimated life expectancy (after TAVR) \\\u003C12 months.\n12. Subject belongs to a vulnerable population.","ALL","18 Years",{"count":20,"type":21},1650,"ESTIMATED","INTERVENTIONAL",[24],"NA","Prospective, randomized, controlled, multicenter, international study.\n\nUp to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved Transcatheter Heart Valve (THV) from the SAPIEN series or the Evolut series and followed for 10 years.\n\nAfter completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'.\n\nUp to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.",[27,28],"Severe Aortic Stenosis","Valve-in-valve Procedures",[30,31,32],"tavr","severe calcific aortic stenosis","failed surgical bioprosthesis","RECRUITING","2026-07-01",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2025-10-21",{"date":41,"type":21},"2038-03",{"name":43,"class":44},"Anteris Technologies Ltd.","INDUSTRY",8,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100477184","aspirin-vs-clopidogrel-after-tavr-100477184","NCT05493657","Aspirin vs Clopidogrel After TAVR","Aspirin Versus Clopidogrel for Leaflet Thrombosis Prevention in Patients Undergoing Transcatheter Aortic Valve Replacement: ACLO-TAVR Trial","Inclusion Criteria:\n\n1. Patients \\>19 years old\n2. Patients who underwent TAVR symptomatic severe AS\n3. Provision of informed consent\n\nExclusion Criteria:\n\n1. Patients requiring dual antiplatelet therapy longer than 4 weeks\n2. Any conditions requiring specific antiplatelet therapy aspirin or clopidogrel\n3. History of stroke or transient ischemic attack (TIA) within 6 months\n4. Planned major surgery\n5. Cardiogenic shock or hemodynamic instability\n6. Chronic kidney disease stage 4 or 5 (eGFR \\\u003C30mL\u002Fmin)\n7. Valve-in-valve TAVR procedure\n8. Hypersensitivity or contraindication to aspirin or clopidogrel\n9. Indication for anticoagulation therapy","19 Years",{"count":55,"type":21},270,[24],"Currently, the optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains still unknown., The purpose of the study is to compare aspirin versus clopidogrel monoantiplatelet therapy for preventive effect on leaflet thrombosis in patients undergoing TAVR for severe aortic stenosis. This study is designed as a prospective, multicenter, open label, randomized controlled study. Eligible patients will be randomized to aspirin or clopidogrel monotherapy after TAVR. Patients will have dual antiplatelet therapy of aspirin 100 mg and clopidogrel 75 mg for 4 weeks after TAVR and then subsequent monoantiplatelet therapy of either aspirin 100 mg or clopidogrel 75 mg according to the randomization. Leaflet thrombosis will be assessed with cardiac computed tomography (CT) and transthoracic echocardiography at 3 months after TAVR. Patients will be clinically followed for 6 months. The primary endpoint is the Incidence of leaflet thrombosis on cardiac CT at 3 months.",[27],"2026-06-29",{"date":61,"type":37},"2026-06-30",{"date":63,"type":37},"2023-02-02",{"date":65,"type":21},"2027-07-21",{"name":67,"class":68},"Yonsei University","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100578954","phase-4-application-of-tavi-at-experienced-interventional-cardiac-centers-without-on-site-cardiac-surgery-atlas-study-100578954","NCT06818006","Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)","Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery","ATLAS","Inclusion Criteria:\n\n* Severe symptomatic AS reviewed and accepted for Transfemoral (TF) TAVI by an established Heart Team\n* Obtained informed consent\n\nExclusion Criteria:\n\n* Ambiguous aortic annular sizing on CT measurement deemed to increase the risk of valve embolization\n* Hostile aortic root on CT for TAVI implantation defined by, but not limited to:\n* High risk LVOT with a dimension significantly smaller than the annulus and\u002For extensive calcification\n* Features that increase the risk of coronary artery occlusion including inadequate coronary artery height and\u002For shallow coronary sinuses in the setting of a significant coronary artery territory at risk (accounting for prior CABG)\n* High risk STJ anatomy defined by inadequate height and\u002For diameter and\u002For excessive calcification\n* Vascular anatomy with increased risk of ascending aorta trauma (i.e. combinations of existing ascending aortic aneurysm, and\u002For unfolded aorta and\u002For extensive tortuosity and\u002For excessive iliofemoral calcification)\n* GFR \\\u003C15, excluding patients on dialysis\n* Life expectancy less than 3 years\n* Any factor precluding 1-year follow-up",{"count":79,"type":21},600,[81],"PHASE4","The purpose of this study is to see if having the Transcatheter Aortic Valve Replacement (TAVR) procedure done in a hospital with onsite cardiac surgery available or not, makes a difference on participant outcomes. Current standard of care is to have this procedure done in a hospital with onsite cardiac surgery available.\n\nHypothesis\n\nThe investigators hypothesize that the TAVR in experienced interventional cardiac centers without on-site cardiac surgery will be safe and effective. Although this is happening clinically in select regions internationally, this change in the clinical application of TAVI requires a rigorous assessment of safety with a robust randomized trial and multicenter international collaboration.",[84,27],"Aortic Stenosis",[84,86,87,88],"TAVR","TAVI","Sever aortic stenosis","NOT_YET_RECRUITING","2026-06-01",{"date":92,"type":37},"2026-06-02",{"date":94,"type":21},"2026-08-01",{"date":96,"type":21},"2030-12",{"name":98,"class":68},"University of Alberta",2,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":108,"targetDuration":110,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100607848","navitor-japan-study-100607848","NCT07193888","Navitor Japan Study","Navitor Japan Post-Market Study","Inclusion Criteria:\n\n1. Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure.\n2. The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the EC of the respective clinical site.\n3. The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU).\n2. Life expectancy \\\u003C 12 months from the time of informed consent due to non-cardiac co-morbid conditions.\n3. In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and\u002For follow-up visits or that could impact scientific integrity of the study.\n4. Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.\n5. Inability to tolerate antiplatelet\u002Fanticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.\n6. Currently participating in an investigational drug or device study that may confound the results of this study.\n7. Anatomy that makes insertion and endovascular access to the aortic valve difficult and\u002For impossible.","100 Years",{"count":109,"type":21},100,"12 Months","OBSERVATIONAL","The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.",[27],[115,116,84,117],"NAVITOR","Transcatheter aortic valve implantation (TAVI)","Cardiovascular Disease","2026-05-21",{"date":120,"type":37},"2026-05-26",{"date":122,"type":37},"2025-10-30",{"date":124,"type":21},"2028-08",{"name":126,"class":44},"Abbott Medical Devices",3,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":138,"studyType":111,"phases":4,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":149,"locationsCount":69},"100640846","a-registry-to-assess-the-efficacy-and-safety-of-transcatheter-treatment-for-aortic-valve-disease-at-the-irccs-policlinico-san-matteo-foundation-in-pavia-italy-100640846","NCT07596394","A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy).","A Prospective and Retrospective Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (PAVI_TAVI Registry).","PAVI_TAVI","Inclusion Criteria:\n\n* Age \\> 18 years.\n* Transcatheter treatment with a bioprosthesis on native aortic valve, on degenerated aortic bioprosthesis, or on degenerated mitral prostheses\u002Frings.\n\nExclusion Criteria:\n\n* Failure to sign the informed consent.",{"count":137,"type":21},500,"5 Years","PAVI-TAVI Registry Overview\n\nThe PAVI-TAVI Registry is an observational study at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy. It tracks real-world outcomes of transcatheter heart valve procedures like TAVI (for aortic stenosis), valve-in-valve (VIV), TAVI for aortic insufficiency (TAVI-IAo), and TMVR (for degenerated mitral valves) in patients over 18 years old.\n\nWho Can Join Eligible patients include adults treated with these procedures on native aortic valves, failed aortic bioprostheses, or degenerated mitral prostheses\u002Frings. The only exclusion is not providing informed consent.\n\nStudy Goals The main goal is to evaluate TAVI's safety and effectiveness over 5 years, focusing on all-cause mortality from the initial procedure. Secondary goals assess complication rates, valve function, inflammation markers, heart failure hospitalizations, heart attacks, strokes, and major cardiac events.\n\nHow It Works No experimental treatments-it's a registry collecting routine clinical data via a secure electronic system. Follow-up happens at your doctor's discretion, ideally at 3 and 12 months, then yearly (often by phone for stable cases). The study aims to enroll 500+ patients.",[27],[142,87,86],"aortic stenosis","2026-05-12",{"date":145,"type":37},"2026-05-19",{"date":147,"type":37},"2021-03-16",{"date":96,"type":21},{"name":150,"class":68},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":69},"100629032","clear-as-ct-ffr-guided-revascularization-in-patients-with-severe-aortic-stenosis-100629032","NCT07469371","CLEAR-AS: CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis","CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis: A Randomized Controlled Trial","CLEAR-AS","Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Severe aortic stenosis confirmed by echocardiography, defined as peak aortic jet velocity (Vmax) ≥4.0 m\u002Fs, mean transvalvular gradient ≥40 mmHg, or aortic valve area (AVA) ≤1.0 cm² \\[or indexed aortic valve area (AVAi) ≤0.6 cm²\u002Fm²\\].\n3. New York Heart Association (NYHA) functional class II or higher.\n4. Eligible for both transfemoral transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).\n5. Undergoing preoperative coronary computed tomography angiography (CCTA).\n6. Willing to participate in the study and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Allergy to prosthetic valve materials or iodinated contrast agents.\n2. Contraindication or allergic reaction to anticoagulants or antiplatelet agents, or inability to tolerate required anticoagulant or antiplatelet therapy.\n3. Active infective endocarditis or any other active infection.\n4. Severe vascular disease precluding safe implantation of a prosthetic valve.\n5. Ascending aortic diameter ≥50 mm.\n6. Prior prosthetic valve implantation in any cardiac position or prior coronary artery bypass grafting (CABG).\n7. Preoperative imaging confirming aortic root anatomy unsuitable for transcatheter aortic valve implantation.\n8. Intracardiac mass, left ventricular or left atrial thrombus, or vegetation confirmed by preoperative echocardiography.\n9. Acute myocardial infarction within 30 days before surgery.\n10. Clinically diagnosed stroke or transient ischemic attack within 3 months before surgery.\n11. Bleeding or coagulation disorders within 3 months before surgery that required hospitalization or blood transfusion or were otherwise clinically significant and would preclude the antiplatelet therapy required in this study.",{"count":160,"type":21},300,[24],"Severe aortic stenosis (AS) is often accompanied by coronary artery disease (CAD). While coronary computed tomography angiography (CCTA) is routinely used before aortic valve replacement (AVR) to evaluate coronary anatomy, it lacks physiological assessment of myocardial ischemia.\n\nThis prospective, single-center, randomized controlled trial aims to evaluate whether integrating functional assessment using CT-derived fractional flow reserve (CT-FFR) with CCTA can optimize revascularization decision-making and improve clinical outcomes. A total of 300 severe AS patients scheduled for transcatheter or surgical AVR will be randomly assigned to either the experimental group (revascularization decisions guided by both CCTA and CT-FFR) or the control group (decisions guided by CCTA alone). Participants will be followed up for 1 year to assess major adverse cardiovascular events and other clinical outcomes.",[27],"2026-04-13",{"date":166,"type":37},"2026-04-16",{"date":168,"type":37},"2026-04-01",{"date":170,"type":21},"2027-12-01",{"name":172,"class":68},"Yan'an Affiliated Hospital of Kunming Medical University",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":179,"maxAge":107,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100624800","safety-and-efficacy-of-the-renatus-transcatheter-aortic-valve-system-for-the-treatment-of-severe-aortic-stenosis-100624800","NCT07414342","Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis","Inclusion Criteria:\n\n1. Patients deemed eligible for TAVR by the treating physician, including those at high, intermediate, or low surgical risk, with a calculated Society of Thoracic Surgeons (STS) risk score;\n2. Symptomatic patients with severe aortic stenosis, defined by echocardiography as having at least one of the following:\n\n   * Mean transvalvular pressure gradient ≥40 mmHg (1 mmHg = 0.133 kPa),\n   * Peak aortic jet velocity ≥4.0 m\u002Fs,\n   * Aortic valve area \\\u003C1.0 cm², or Indexed effective orifice area \\\u003C0.6 cm²\u002Fm²;\n3. Patients who understand the purpose of the trial, voluntarily agree to participate, provide written informed consent, and are willing to undergo required examinations and clinical follow-up.\n\nExclusion Criteria:\n\n1. Patients with a life expectancy of ≤1 year following prosthetic valve implantation;\n2. Patients who have experienced an acute myocardial infarction or undergone any therapeutic cardiac surgery within the past month;\n3. Patients with minimal or no calcification of the aortic annulus;\n4. Patients with aortic root anatomy or pathology deemed unsuitable for prosthetic valve implantation;\n5. Patients with multivalvular disease (severe stenosis and\u002For regurgitation);\n6. Patients with hematologic cachexia, including leukopenia (WBC \\\u003C3×10⁹\u002FL), acute anemia (Hb \\\u003C90 g\u002FL), thrombocytopenia (PLT \\\u003C50×10⁹\u002FL), bleeding diathesis, or coagulopathy;\n7. Patients with untreated coronary artery disease requiring revascularization;\n8. Patients with obstructive hypertrophic cardiomyopathy;\n9. Patients with severe left ventricular dysfunction (LVEF \\\u003C20%);\n10. Patients with severe right ventricular dysfunction;\n11. Patients with intracardiac masses, fresh thrombi, or vegetations detected by echocardiography;\n12. Patients unable to tolerate anticoagulant or antiplatelet therapy;\n13. Patients who have experienced a cerebrovascular accident (CVA)-including ischemic or hemorrhagic stroke-within the past 3 months;\n14. Patients with decompensated renal insufficiency;\n15. Patients with active infective endocarditis or other active infections;\n16. Patients with untreated conduction system disease requiring pacemaker implantation;\n17. Patients who have participated in another drug or medical device clinical trial and have not yet reached the primary endpoint assessment timepoint;\n18. Any other condition, as determined by the investigator, that renders the patient unsuitable for transcatheter aortic valve intervention.","60 Years",{"count":181,"type":21},800,[24],"This study is a prospective, non-randomized, observational, post-market follow-up trial designed to evaluate the safety and efficacy of the RENATUS® Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.",[27],"2026-02-10",{"date":187,"type":37},"2026-02-17",{"date":189,"type":21},"2026-02",{"date":191,"type":21},"2037-09",{"name":193,"class":44},"Beijing Balance Medical Technology Co., Ltd",4,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":221},"100585109","transfemoral-tavi-with-or-without-coronary-angiogram-in-patients-with-severe-aortic-stenosis-pure-tavi-100585109","NCT06898086","Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI)","Treatment of Severe Aortic Stenosis With Transfemoral TAVI With or Without Coronary Angiogram During Diagnostic Work-up (PURE TAVI)","PURETAVI","Inclusion Criteria:\n\n* Patient is older than 18 years with severe AS considered for TAVI by a multidisciplinary heart team.\n* Patient is candidate for transfemoral TAVI as per local standards and current guidelines.\n* Patient is willing and capable to give written consent to participate to the trial and confirmed to be able to attend the expected follow up visits.\n\nExclusion Criteria:\n\n* Patient had a coronary angiogram with or without PCI and\u002For coronary CT and\u002For CABG within last 5 years.\n* Left main PCI in the medical history\n* Patient has CCS of 3 or more.\n* Patient has left ventricular ejection fraction \\\u003C30%.\n* Patients in whom TAVI through femoral access is ad priori not possible based on clinical assessment or medical history\n* Patient has been treated for acute myocardial infarction within 30 days before randomization.\n* Patient has a planned open-heart surgery.\n* Patient has a life expectancy less than 1 year due to other severe non-cardiac disease.\n* Patient is participating in another clinical study with an investigational product that has not yet completed the follow up period.\n* Patient has received previous treatment for aortic valve implantation or replacement.\n* Female patient who is pregnant at the time of inclusion and female patient of childbearing potential","120 Years",{"count":205,"type":21},620,[24],"This study will be conducted in patients with severe aortic stenosis who are referred for transcatheter aortic valve implantation (TAVI). TAVI is the recommended treatment for severe aortic stenosis. Currently, before undergoing TAVI, most patients undergo a coronary angiography to check whether the coronary arteries are blocked and to assist in appropriate valve sizing. If significant blockages are detected, they are treated before or during TAVI.\n\nHowever, many patients who undergo TAVI are older and often have additional cardiovascular conditions such as hypertension, diabetes, or obesity. These comorbidities increase the risk of complications related to coronary angiography, including kidney injury from contrast dye, bleeding, and vascular complications at the access site. As such, it remains uncertain whether routine coronary angiography is necessary for all patients undergoing TAVI, particularly those without symptoms suggestive of myocardial ischemia.\n\nThis study aims to determine whether a TAVI treatment pathway without prior coronary angiography is non-inferior to the standard pathway that includes routine coronary angiography, with or without revascularization, in patients with severe aortic stenosis who do not have typical angina symptoms (defined as Canadian Cardiovascular Society Class \\\u003C3). \"Non-inferior\" means the study seeks to show that omitting routine coronary angiography is at least as effective and safe as the standard approach.\n\nAll participants will receive a CE-certified Myval™ balloon-expandable transcatheter heart valve. This device is commercially available and designed to provide accurate positioning and reliable valve function.\n\nThis is a multicentre, investigator-initiated clinical study sponsored by Rede Optimus (RO), Alte Steinhauserstrasse 1, 6330 Cham, Switzerland. RO conducts independent research to address unresolved questions in vascular medicine. The study is financially supported by Meril Life Sciences Pvt. Ltd., Bilakhia House, Survey No.135\u002F139, Muktanand Marg, Chala, Vapi 396191, Gujarat, India.\n\nApproximately 620 patients will be enrolled across 20 centres in 7 European countries. The total study duration is expected to be 42 months, with an 18-month enrollment period and 24-month follow-up for each participant.",[27],[210],"PURE TAVI","2026-02-04",{"date":213,"type":37},"2026-02-09",{"date":215,"type":37},"2025-08-08",{"date":217,"type":21},"2028-10-30",{"name":219,"class":220},"Rede Optimus Hospitalar SA","NETWORK",23,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":230,"targetDuration":232,"studyType":111,"phases":4,"briefSummary":233,"conditions":234,"keywords":238,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":99},"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",{"count":231,"type":21},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",[27,235,236,237],"Cardiogenic Shock","Cardiogenic Shock, ECMO","Trans-catheter Aortic Valve Implantation",[239,240,86],"severe aortic stenosis","cardiogenic shock","2025-12-15",{"date":243,"type":37},"2025-12-30",{"date":245,"type":21},"2026-01-01",{"date":247,"type":21},"2027-06-30",{"name":249,"class":68},"Atlantic Health System",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":17,"minAge":258,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100529387","comparison-of-a-single-versus-double-perclose-technique-for-tavr-100529387","NCT06173115","Comparison of a Single Versus Double Perclose Technique for TAVR","The Utilization of Single Versus Double Perclose Devices for Transfemoral Aortic Valve Replacement Access Site Closure: A Prospective, Multicenter, Randomized Controlled Trial","Single","Inclusion Criteria:\n\n* Patients scheduled to undergo transfemoral TAVR were considered for inclusion in the trial if they met all inclusion and none of the exclusion criteria. Inclusion criteria were an indication for TAVR as judged by the local heart team; selection of the transfemoral access route and a commercially available transcatheter aortic valve; and willingness to comply with protocol specified follow-up evaluations.\n\nExclusion Criteria:\n\n* Principal exclusion criteria were a vascular access site anatomy not suitable for percutaneous vascular closure and the occurrence of vascular access site complications before the TAVR procedure. Additional exclusion criteria were a known allergy or hypersensitivity to any VCD component; unstable active bleeding or bleeding diathesis or significant unman ageable anemia; absence of computed tomographic data of the access site before the procedure; systemic infection or a local infection at or near the access site; life expectancy of \\\u003C6 months because of noncardiac conditions; patients who can-not adhere to or complete the investigational protocol for any reason; pregnant or nursing patients; and participation in any other interventional trial.","65 Years",{"count":260,"type":21},876,[24],"Transcatheter aortic valve replacement (TAVR) has become widely recognized as a minimally invasive approach for aortic valve replacement in patients with severe aortic stenosis. It has been proven to be a safe and effective option for patients who are at low, intermediate, and prohibitive risk for surgical valve replacement.\n\nOne of the critical components of procedural success in a transfemoral approach is access site management, as vascular complications strongly correlate with adverse outcomes. When major vascular complications occur, there are higher rates of major bleeding, transfusions, and renal failure requiring dialysis, as well as a significantly higher rate of 30-day and 1-year mortality. In recent years, a \"preclosure\" technique has emerged as a common vascular closure approach using a Perclose Proglide system (Abbott Vascular), in which sutures are deployed before dilating the arterial access site. This allows for arterial closure after dilation to sizing up to larger bore access sheaths that accommodate valve delivery systems. The sutures are subsequently harvested and tightened to close the large bore arteriotomy site at the end of the case. It has been demonstrated that the use of two Perclose devices, or double Perclose closure, is an effective closure technique with a low rate of vascular complications. A large number of TAVR centers have adopted this method for large-bore vascular closure. In the past, there have been few investigations comparing the utilization of a single Perclose device compared to a double Perclose technique. There are numerous theoretical advantages to the use of a single device, which include decreased procedural cost and procedural time. The investigation aimed to determine if there are clinical benefits as well using the single Perclose approach.",[27],[265,266,267],"transcatheter aortic valve replacement","vascular closure devices","randomized control trial","2025-10-12",{"date":270,"type":37},"2025-10-14",{"date":272,"type":37},"2023-10-20",{"date":274,"type":21},"2026-06-28",{"name":276,"class":68},"Second Affiliated Hospital, School of Medicine, Zhejiang University",25,{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":194},"100552742","act-on-quality-of-life-in-patients-with-aortic-stenosis-100552742","NCT06477042","Act on Quality of Life in Patients With aortIc Stenosis","Act on Quality of Life in Poor Prognosis Aortic Stenosis Patients","ALPINIST","Inclusion Criteria:\n\n* Patients with symptomatic aortic stenosis (exertional dyspnea, angina, malaise\u002Fsyncope)\n\n  * Indication for TAVI (valve area 1 cm² or 1 cm²\u002Fm² body surface area or mean transvalvular aortic gradient \\> 40 mmHg on ultrasound) validated in Heart Team\n  * Charlson score ≥ 5\n  * Social health care insurance affiliation\n\nExclusion Criteria:\n\n* Patient refusing TAVI procedure\n* CT scan not performed during the pre-TAVI assessment\n* Patient unable to understand or answer quality-of-life questionnaires\n* Pregnant or breast-feeding women\n* Patients participating in other interventional research that may interfere with the present study with an exclusion period still in progress\n* Persons under judicial protection\n* Patients under guardianship, curators or safeguard of justice",{"count":287,"type":21},240,"Aortic stenosis (AS) is a degenerative process affecting the aortic valve that leads to sclerosis of the valve and limits its opening during cardiac contractions. The prognosis is poorly, with survival rates of only 15-50% at 5 years. AS has a major impact on quality of life, with severely limiting symptoms (dyspnea, chest pain,…) often leading to repeated hospitalizations. It is the most common valvular disease in Europe and North America, and its prevalence is increasing as the population ages. In Europe, 17% of the population is aged 65 or over; in France, this proportion will reach 30% by 2030, corresponding to 16 million people. The incidence of aortic valve sclerosis (early stage AS) is around 25% at age 65, rising to 48% after age 75. The prevalence of aortic valve disease is likely to continue to rise, given the expected evolution of the age pyramid.\n\nThere is no medical treatment able to slow down the degenerative process of the valve, and the only treatment is aortic valve replacement when the AS becomes constricted and the patient is eligible for an intervention. Aortic valve replacement has historically been performed surgically, with open-chest surgery to remove the damaged valve and replace it with a mechanical or biological valve prosthesis. Now Transcatheter Aortic Valve Implantation (TAVI) has replaced this procedure. This involves inserting a bioprosthesis crimped into a stent via an endovascular route, i.e. without opening the thorax. Deployment of the stent crushes the native valve, leaving the functional bioprosthesis in place.\n\nInitially developed for patients contraindicated to surgery, TAVI is now offered as a first-line treatment for patients aged 75 and over.\n\nInexistent before 2010, the number of TAVIs equalled the number of surgeries by 2015, and TAVIs currently account for ¾ of aortic valve procedures (unpublished data).",[27],[87,291,84],"quality of life","2025-01-16",{"date":294,"type":37},"2025-01-17",{"date":296,"type":37},"2024-12-19",{"date":298,"type":21},"2027-12-19",{"name":300,"class":68},"Hospices Civils de Lyon",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":17,"minAge":308,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":69},"100526568","a-prospective-multicenter-single-arm-study-to-evaluate-a-transcatheter-aortic-valve-system-safety-and-efficacy-for-the-treatment-of-patients-with-severe-aortic-stenosis-100526568","NCT06136429","A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis","A Prospective, Multicenter, Single-arm Target-value Clinical Trial To Evaluate the Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis","Inclusion Criteria:\n\n1. Age≥ 70 years;\n2. Patients with symptomatic severe aortic stenosis (mean pressure gradient across the aortic valve ≥ 40 mmHg (1 mmHg = 0.133 kPa) on echocardiography, or trans-aortic valve blood flow velocity ≥ 4.0 m\u002Fs, or aortic orifice area ≤ 1.0 cm2, or effective aortic orifice area index ≤0.6 cm2\u002Fm2)\n3. NYHA Grading ≥ Level II;\n4. Life expectancy of more than 1 year after implantation of the prosthetic valve;\n5. Assessed by not less than two cardiothoracic surgeons, documented as a contraindication to surgery, or documented as unsuitable for conventional surgery;\n6. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-up.\n\nExclusion Criteria:\n\n1. The imaging data shows that it is anatomically unsuitable for transcatheter aortic valve implantation;\n2. Acute myocardial infarction (defined as Q-wave myocardial infarction, or non-Q-wave myocardial infarction with CK-MB≥ twice normal and\u002For elevated Tn (WHO definition)) occurring within 1 month before valve implantation);\n3. Received any therapeutic traumatic cardiac surgery (other than coronary revascularization) within 1 month before valve implantation;\n4. Implanted prosthetic heart valves at any location, or combined with other valves with severe stenosis or severe regurgitation;\n5. Hemorrhagic constitution or coagulation dysfunction (platelet PLT\\\u003C50×10\\^9\u002FL);\n6. Haemodynamic instability requiring continuous mechanical cardiac assistance;\n7. Severe left ventricular dysfunction, left ventricular ejection fraction LVEF \\\u003C20%;\n8. Echocardiography shows intracardiac thrombosis or vegetation, etc.;\n9. Renal insufficiency decompensation (endogenous creatinine clearance rate\\\u003C20ml\u002Fmin);\n10. Active peptic ulcer or upper gastrointestinal bleeding within 3 months;\n11. Cerebrovascular events (CVAs) within 3 months before valve implantation, excluding transient ischemic attack;\n12. Allergy or contraindication to antiplatelet drugs, anticoagulant drugs, or contrast agents, resulting in the inability to perform preoperative or appropriate intraoperative medication, allergies, or contraindications to polymer materials;\n13. Patients with active infective endocarditis or other active infections;\n14. Concurrent participation in other drug or device studies.\n15. In the opinion of the investigator, it is not suitable for enrollment.","70 Years",{"count":310,"type":21},120,[24],"Trial Title: Prospective, multicenter, single-arm target value clinical trial to evaluate the safety and efficacy of a transcatheter aortic valve system in the treatment of patients with severe aortic stenosis Test device: Transcatheter aortic valve system. Pilot Phase: Clinical Validation of Class III Medical Devices. Study design: prospective, multicenter, single-group target value. Sample size: 120 cases. Intended Use: The Transcatheter Aortic Valve System is indicated for patients with a diagnosis of severe aortic stenosis by the Comprehensive Heart Team.\n\nObjective: This clinical trial is a prospective, multicenter, single-arm study to evaluate the safety and efficacy of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis.\n\nPrimary endpoint: 12-month postoperative all-cause mortality All-cause deaths include cardiac death and non-cardiac death. Secondary Endpoints: 1. Device success rate 2. Procedural success rate 3. Delivery system performance 4. Retrieval system performance (e.g. using a recycling system) 5. Exchange system performance 6. Valvular function at Immediately postoperative, 7 days\u002Fat discharge, 30 days, 6 months, 12 months, 2-5 years follow-up: valve stenosis, regurgitation, valve function (e.g., opening area, pressure gradient), paravalvular leakage 7. Improvement in quality of life at 30 days, 6 months, 12 months postoperatively 8. Improvement in cardiac function at 7 days\u002Fat discharge, 30 days, 6 months, 12 months, 2-5 years postoperatively\n\nExperimental design:\n\nThis trial is a prospective, multicenter, single-group clinical study with a target value to evaluate the Transcatheter Aortic Valve system Safety and efficacy in the treatment of patients with severe aortic stenosis with 12 months of All-cause mortality after transcatheter aortic valve implantation.\n\nThe mortality rate was the primary study endpoint, and after statistical assumptions and sample size calculations, 120 patients were planned to be enrolled.\n\nPatients were clinically followed immediately after valve implantation, 7 days postoperatively\u002Fat discharge, 30 days, 6 months, 12 months, and 2-5 years postoperatively.\n\nIn this trial, all relevant clinical data were collected, sorted out and statistically analyzed by an independent data management and statistics center and a clinical monitoring institution. All enrolled subjects underwent outpatient follow-up at 30 days, 6 months, and 12 months after surgery, and performed relevant imaging examinations (ultrasound, etc.) and laboratory tests and safety evaluations, and continuous follow-up and cardiac ultrasound examinations were performed annually at 2-5 years to observe the occurrence of adverse events to evaluate the long-term safety of the transcatheter aortic valve system.\n\nThe safety and efficacy of the transcatheter aortic valve system were evaluated with the subject's 12-month postoperative all-cause mortality as the primary endpoint, and the immediate postoperative device success rate, procedural success, retrieval system performance, valve function, cardiac function improvement, quality of life improvement, all-cause mortality in different follow-up periods, major adverse cardiovascular and cerebrovascular events, myocardial infarction, stroke, hemorrhage, acute kidney injury, permanent pacemaker implantation, serious vascular complications, and other TAVR-related complications were taken as the secondary endpoints to assist in evaluating the safety and efficacy of the test product, and to provide a basis for the final official listing and domestic marketing.",[27],"2023-11-13",{"date":316,"type":37},"2023-11-18",{"date":318,"type":37},"2023-10-18",{"date":320,"type":21},"2029-12-30",{"name":322,"class":68},"Pan Xiangbin",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":17,"minAge":330,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":344},"100364792","colibri-transcatheter-aortic-heart-valve-system-study-100364792","NCT04029844","Colibri Transcatheter Aortic Heart Valve System Study","A Prospective, Single Arm Clinical Investigation Evaluating Safety and Performance of the Colibri Transcatheter Aortic Heart Valve System for the Treatment of Symptomatic Severe Aortic Stenosis Via Transfemoral Access in High Surgical Risk Patients","Inclusion Criteria:\n\n* 1\\. Subject of age \\> 75 years\n* 2\\. Subject suffering from severe aortic tricuspid valve stenosis defined as follows: High-gradient aortic stenosis (mean pressure gradient across aortic valve \\> 40 mmHg or peak velocity \\> 4.0 m\u002Fs)\n* 3\\. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) \\> Class II\n* 4\\. Subject with a documented local Heart Team (HT) agreement of high surgical risk as described in the population\n* 5\\. ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus \\> 22 mm and \\\u003C 27.4 mm\n* 6\\. Subject deemed eligible by a TAVI Centralized Case Review Committee (CRC)\n* 7\\. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow-up requirements\n\nExclusion Criteria:\n\n* 1\\. Arterial aorto-iliac-femoral axis unsuitable for transfemoral access as assessed by conventional angiography and\u002For multidetector computed tomographic angiography (access vessel diameter incompatible with a 16F sheath introducer)\n* 2\\. Aortic root anatomy condition or lesion preventing implantation or access to the aortic valve\n* 3\\. Non-calcific acquired aortic stenosis\n* 4\\. Native unicuspid\u002Fbicuspid aortic valve or congenital aortic valve abnormality\n* 5\\. Previous implantation of heart valve in any position\n* 6\\. Severe aortic regurgitation (\\> 3+)\n* 7\\. Severe mitral regurgitation (\\> 3+)\n* 8\\. Severe tricuspid regurgitation (\\> 3+)\n* 9\\. Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) \\\u003C 30%)\n* 10\\. Echocardiographic evidence of intracardiac mass, thrombus or vegetation\n* 11\\. Multi-vessel coronary artery disease (CAD) with a Syntax Score or residual Syntax Score \\> 22 and\u002For unprotected left main coronary artery\n* 12\\. Cardiogenic shock\n* 13\\. Untreated cardiac conduction disease in need of pacemaker implantation\n* 14\\. Uncontrolled atrial fibrillation (resting heart rate (HR) \\> 120bpm)\n* 15\\. Active and\u002For suspicion of endocarditis or ongoing sepsis\n* 16\\. Blood dyscrasias defined as: leukopenia (White Blood Cells (WBC) \\\u003C 1,000\u002Fmm3), thrombocytopenia (Platelets (PLT) \\\u003C 50,000\u002Fmm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states\n* 17\\. Evidence of acute myocardial infarction (MI) less than 30 days before signing informed consent\n* 18\\. Any need for emergency surgery\n* 19\\. Recent (\\\u003C 6 months of signing informed consent) CerebroVascular Accident (CVA) or Transient Ischemic Attack (TIA)\n* 20\\. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis \\\u003C 30 days prior to signing informed consent\n* 21\\. Any active bleeding that precludes anticoagulation\n* 22\\. Liver failure (Child-C)\n* 23\\. End-stage renal disease requiring chronic dialysis or creatinine clearance \\\u003C 20cc\u002Fmin\n* 24\\. Pulmonary hypertension (systolic pressure \\>80mmHg)\n* 25\\. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by a Forced Expiratory Volume (FEV1) \\\u003C 750cc\n* 26\\. Refusal of blood transfusion\n* 27\\. A known hypersensitivity or contraindication to all anticoagulation\u002Fanti-platelet regimens (or inability to be anticoagulated for the index procedure), to cobalt chromium, to porcine and\u002For collagen, to glutaraldehyde or contrast media\n* 28\\. Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow-up procedures\n* 29\\. Currently participating in another drug or device trial (excluding observational registries) for which the primary endpoint has not been assessed\n* 30\\. Estimated life expectancy of less than 12 months\n* 31\\. For females, pregnancy or intention to become pregnant prior to completion of all follow-up procedures\n* 32\\. Inability to comply with the clinical investigation requirements\n* 33\\. Subject under judicial protection, tutorship or curatorship (for France only)","75 Years",{"count":231,"type":21},[24],"The Colibri Heart Valve clinical investigation (\"COL-01\") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results. This study will be conducted in about 7 European sites. The study will evaluate the safety and performance of the Colibri Transcatheter Aortic Heart Valve System for the treatment of symptomatic severe aortic stenosis via transfemoral access in high surgical risk patients.\n\n30 subjects suffering from symptomatic severe aortic tricuspid valve stenosis and who are at high surgical risk (logistic EuroSCORE I \\> 20% or other risk factors not included in this score such as frailty, porcelain aorta, sequelae of chest radiation or logistic EuroSCORE I \\\u003C 20% but considered at high risk by local Heart Team evaluation) will be enrolled in this clinical investigation.\n\nThe primary objective of this clinical investigation is to evaluate the all-cause mortality at 30 days post implantation. The secondary objectives are to evaluate the safety and performance of the investigational device at 30 days, 6 and 12 months, and 2, 3, 4, 5 years post implantation.",[27],"2023-02-20",{"date":337,"type":37},"2023-02-21",{"date":339,"type":37},"2021-09-15",{"date":341,"type":21},"2028-07",{"name":343,"class":44},"Colibri Heart Valve LLC",5,{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":17,"minAge":308,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":69},"100368349","safety-and-performance-study-of-the-optimum-transcatheter-aortic-valve-100368349","NCT04076150","Safety and Performance Study of the Optimum Transcatheter Aortic Valve","A First-in-Human Study to Access Feasibility and Safety of the Optimum Aortic Valve Implant","Inclusion Criteria:\n\n1. Willing and capable to provide informed consent;\n2. 70 years of age or older;\n3. Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve Effective Orifice Area (EAO) ≤ 1.0 cm2 or 0.6 cm2\u002Fm2, mean aortic valve gradient ≥35 mmHg or peak aortic valve velocity \\> 4 m\u002Fsec.\n4. Symptomatology due to native aortic stenosis resulting in a New York Heart Association (NYHA) functional classification of II or greater.\n5. Aortic valve annular diameter ≥ 21 and ≤ 23mm measured by MSCT (Multi-Slice Computed Tomography).\n6. A STS (Society of Thoracic Surgeons) score ≥ 8; or Logistic EuroScore I ≥ 15; or a determination by the local heart team that the co-morbidities not captured by the STS or EuroScore are expected to increase the operative mortality risk to \\> 15%.\n7. Geographically available and willing to comply with follow up.\n\nExclusion Criteria:\n\n1. Congenital unicuspid or bicuspid aortic valve;\n2. Noncalcified aortic valve;\n3. Valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success;\n4. Severe (Grade 3 to 4) aortic, mitral, or tricuspid valve regurgitation;\n5. Moderate to severe mitral stenosis;\n6. Myocardial infarction within the past 30 days\\*\n7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;\n8. LVEF (Left Ventricular Ejection Fraction) \\\u003C 30%;\n9. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure;\n10. Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months; \\*\n11. Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery;\n12. Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy;\n13. Patient ineligible for or refuses blood transfusions;\n14. Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity or small vessels) that would preclude passage of catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT;\n15. Gastrointestinal bleeding within the past 30 days; \\*\n16. Stroke or transient ischemic attack (TIA) within past 3 months;\\*\n17. Renal insufficiency as demonstrated by a serum creatinine \\> 3.0 mg\u002FdL;\n18. End stage renal disease requiring chronic dialysis;\n19. Active infection requiring ongoing treatment;\n20. Need for emergent surgery or intervention other than the investigational procedure;\n21. Hypersensitivity or contraindication to procedural medication(s) and device material(s) (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated;\n22. Life expectancy \\\u003C 1 year due to non-cardiac co-morbid conditions;\n23. Currently participating in any other investigational drug or device study;\n24. Patient lacking capacity to provide informed consent (history of any cognitive or mental health status that would interfere with study participation)\n25. Subject found to have an International Normalized Ratio (INR) greater than 2.0 right before the procedure.\n\n    * At the time of procedure, if a subject's medical status has changed since enrollment, the subject shall be re-evaluated for eligibility.",{"count":344,"type":21},[24],"The TAVI (Thubrikar Aortic Valve, Inc.) -1 Study: Safety and Performance Study of the Optimum Transcatheter Aortic Valve- First-in-human study to assess feasibility and safety of the Optimum Aortic Valve Implant",[27],"2022-09-14",{"date":358,"type":37},"2022-09-21",{"date":360,"type":37},"2022-05-18",{"date":362,"type":21},"2027-05-18",{"name":364,"class":44},"Thubrikar Aortic Valve, Inc."]