[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bicuspid-aortic-valve-bav\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bicuspid-aortic-valve-bav":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,76,107,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100579915","sapien-3-transcatheter-aortic-valve-replacement-in-young-aortic-valve-stenosis-patients-from-china-100579915",false,"NCT06830499","Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China","Safety, Effectiveness and Durability of Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China","Inclusion Criteria:\n\nSubjects must meet ALL of the following inclusion criteria to be eligible for participation:\n\n* 50 years of age or older but ≤70 years old at time of consent.\n* Severe AS, defined as follows:\n\n  a) For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND maximal aortic velocity ≥5.0 m\u002Fsec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \\\u003C50%.\n* Tricuspid aortic valve stenosis and type-1 bicuspid aortic valve anatomy confirmed by MDCT.\n* The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.\n* Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant.\n* The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.\n\nExclusion Criteria:\n\nSubjects are NOT eligible for participation if they meet ANY of the following exclusion criteria:\n\n* Any of the following: a. no calcification; b. challenging calcification based on physician's experience and discretion (Case Review Board would decide whether to exclude challenging calcification cases).\n* Aortic valve is a congenital unicuspid valve, congenital Type-0 or Type-2 bicuspid valve, or quadricuspid valve.\n* Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR.\n* Evidence of an acute myocardial infarction ≤ 1 month (30 days), with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.\n* Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease).\n* Aortic disease: a. bicuspid aortic valve with an ascending aorta diameter ≥ 45mm b. tricuspid aortic valve with an ascending aorta diameter ≥ 50mm.\n* Pre-existing mechanical or bioprosthetic valve in any position.\n* Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit.\n* Emergency interventional\u002Fsurgical procedures within 30 days of the valve implant procedure.\n* Hypertrophic cardiomyopathy with or without obstruction.\n* Ventricular dysfunction with LVEF \\\u003C 30%.\n* Cardiac imaging (echo, CT, and\u002For MRI) evidence of ventricular mass, thrombus or vegetation.\n* Inability (including allergy) to heparin, iodine contrast agent, warfarin or NOAC, aspirin or clopidogrel.\n* Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure.\n* Renal replacement therapy at the time of screening.\n* Severe lung disease (FEV1 \\\u003C 50% predicted) or currently on home oxygen.\n* Estimated life expectancy \\\u003C 24 months.\n* Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary.","ALL","50 Years","70 Years",{"count":20,"type":21},450,"ESTIMATED","OBSERVATIONAL","Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study",[25,26],"AORTIC VALVE DISEASES","Bicuspid Aortic Valve (BAV)",[28,29,30,31],"TAVR","real-world","aortic valve stenosis","Sapien 3","RECRUITING","2026-05-21",{"date":35,"type":36},"2026-05-27","ACTUAL",{"date":38,"type":36},"2025-04-24",{"date":40,"type":21},"2031-06-30",{"name":42,"class":43},"Xijing Hospital","OTHER",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":55,"studyType":22,"phases":4,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100232633","cardiovascular-health-improvement-project-100232633","NCT02306200","Cardiovascular Health Improvement Project","CHIP","Inclusion Criteria:\n\n* Any patient over the age of 18 who is able\u002Fwilling to give informed consent\n* Patients \\\u003C18 years of age with parental consent and assent (if assent is applicable for their age)\n* Diagnosis of:\n* aortic pathology potentially due to a known or suspected inherited condition\n* Idiopathic aortic aneurysm\n* Interesting of novel vascular pathology in the aorta or main branches\n* Family history of aortic or vascular disease\n* Other cardiovascular disease\n* Healthy controls with no apparent cardiovascular disease\n\nExclusion Criteria:\n\n\\- Not willing or able to sign the consent",true,{"count":54,"type":21},15000,"40 Years","The goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls.",[58,59,26,60,61],"Aortic Aneurysm","Aortic Dissection","Heart Failure","Cardiovascular Diseases",[63,64,65,26,59],"Aorta","Abdominal Aortic Aneurysm (AAA)","Thoracic Aortic Aneurysm (TAA)","2026-04-23",{"date":68,"type":36},"2026-04-29",{"date":70,"type":4},"2013-08",{"date":72,"type":21},"2053-08",{"name":74,"class":43},"University of Michigan",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":44},"100582948","towards-a-more-standardized-bicuspid-aortic-valve-repair-rationale-and-design-of-contour-trial---a-randomized-trial-100582948","NCT06869954","Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial - a Randomized Trial","Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial","CONTOUR","Inclusion Criteria:\n\n1. Presence of fused BAV phenotype with an asymmetric configuration (commissural orientation \\\u003C 170 degree) \\[14\\]\n2. Severe aortic regurgitation (vena contracta (vc) \\> 6mm and\u002For pressure half-time (PHT) \\\u003C 200 ms and\u002For effective regurgitant orifice area (EROA) \\> 30 mm2 and\u002For regurgitant volume (RV) \\> 60 ml\u002Fbeat and\u002For left ventricular end-systolic diameter (LVESD) \\> 50mm (or indexed LVESD \\> 20mm\u002Fm2 BSA) and\u002For regurgitation fraction (RF) in cardiothoracic MRI \\> 40%) (at least one parameter is required) \\[15\\]\n3. Isolated aortic valve surgery or concomitant procedure (including CABG and\u002For mitral\u002Ftricuspid valve surgery and\u002For ascending aortic surgery)\n4. Willingness to participate and written informed consent\n5. Age at surgery \\> 18 years\n\nExclusion Criteria:\n\n1. Moderate\u002Fsevere BAV stenosis (pmean \\> 20mmHg)\n2. Moderate\u002Fsevere BAV cusp calcifications extending beyond the raphe region and\u002For necessitating patch implantation (deemed irreparable based on preoperative TOE (as by decision of the operating surgeon)\n3. Concomitant aortic root aneurysm \\> 45mm requiring simultaneous aortic root surgery \\[16\\]\n4. Acute\u002Fsubacute BAV endocarditis\n5. Contraindication to MRI","18 Years",{"count":86,"type":21},100,"INTERVENTIONAL",[89],"NA","Background: Between one-third and one-half of patients with bicuspid aortic valve (BAV) disease develop significant aortic regurgitation (AR) at a young age, leading to cardiomyopathy and heart failure. Aortic valve repair is an evolving and still underused strategy in BAV patients with AR. The lack of sufficient standardization remains the main limitation of current repair techniques, resulting in an increased risk of AR recurrence and reoperation. The most controversial issue is the stabilization of the BAV annulus. The CONTOUR trial aims to compare two different BAV annuloplasty concepts in a prospective randomized study.\n\nMethods: CONTOUR is a multicenter, randomized controlled trial designed to enroll 100 consecutive BAV patients with AR across four sites in Germany. BAV AR patients with an asymmetric configuration and without concomitant root aneurysm will be randomized 1:1 to undergo aortic valve repair using an internal HAART 200 annuloplasty device (i.e., INTERNAL group) (n=50) or external annuloplasty (i.e., double external ring annuloplasty) in the EXTERNAL group (n=50). 4D flow MRI will be performed preoperatively (t1), postoperatively at discharge (t2), and at 1-year follow-up (t3) for rater-blinded assessment of hemodynamic profiles (i.e., flow eccentricity) and regurgitation fraction at the MRI core-lab. Two hierarchically ordered primary endpoints will be considered: (1) postoperative reduction of flow eccentricity at hospital discharge and (2) regurgitation fraction (%) at 1-year follow-up.\n\nDiscussion: The CONTOUR trial is designed to test the hypothesis that an internal annuloplasty device, creating a completely symmetric post-repair BAV geometry, achieves superior aortic valve repair outcomes compared to external annuloplasty. If our hypothesis is confirmed, our study will significantly influence aortic valve repair practice and contribute to the refinement of guideline recommendations in the management of BAV patients with AR.",[26,92],"Aortic Regurgitation Disease",[94,95,96,97],"aortic regurgitation","aortic valve repair","annuloplasty","bicuspid aortic valve","2025-10-01",{"date":100,"type":36},"2025-10-07",{"date":102,"type":36},"2025-05-21",{"date":104,"type":21},"2027-06",{"name":106,"class":43},"University Hospital Augsburg",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":118,"studyType":22,"phases":4,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":75},"100577724","a-study-of-chinese-congenital-bicuspid-aortic-valve-100577724","NCT06802016","A Study of Chinese Congenital Bicuspid Aortic Valve","A Cohort Study of Congenital Bicuspid Aortic Valve","Inclusion Criteria:\n\n* The patients were aged 14-60 years;\n* Definitive diagnosis of BAV by imaging (echocardiography, aortic CTA, cardiac magnetic resonance, etc.)\n* Patients were informed about the nature of the study and agreed to participate in all the terms of the study and signed an informed consent form approved by the ethics committee.\n\nExclusion Criteria:\n\n* Poor patient compliance and inability to complete follow-up visits as required;\n* Rheumatic heart valve disease, other organic valve disease.\n* Hyperthyroidism, severe anemia, and other factors that significantly affect hemodynamics.\n* Other circumstances that the researcher believes should be excluded.","14 Years","60 Years",{"count":117,"type":21},500,"10 Years","Pervious studies indicated that the prevalence of bicuspid aortic valve（BAV） might be higher in China. There is a familial predisposition to the development of BAV. The study analyzed epidemiological data on selected BAV and established a BAV cohort to observe disease progression and treatment outcomes.",[26],[122,123,124,125,126],"Bicuspid Aortic Valve","Dilated ascending aorta","Aortic regurgitation","Aortic stenosis","Acoustic cardiography","2025-01-30",{"date":129,"type":36},"2025-02-03",{"date":131,"type":36},"2025-01-18",{"date":133,"type":21},"2035-12-31",{"name":135,"class":43},"Ruijin Hospital",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":5},"100566648","size-up-bicuspid-with-the-lira-method-the-sublime-study-100566648","NCT06657911","Size Up Bicuspid With the LIra MEthod: the SUBLIME Study","SUBLIME: Size Up Bicuspid With the LIra MEthod: the SUBLIME Study","SUBLIME","Inclusion Criteria:\n\n* All patients over 18 years old with severe aortic stenosis and type 1 or 2 BAV according to Sievers classification) undergone TAVR with self-expanding supra-annular prostheses sized according to the LIRA method between September 2018 and June 2024\n\nExclusion Criteria:\n\n* Redo-TAVR\n* TAVR performed in emergency setting\n* TAVR performed for severe aortic regurgitation",{"count":145,"type":21},250,"Transcatheter aortic valve replacement (TAVR) outcomes in patients with raphe-type bicuspid aortic valve (BAV) are still suboptimal for the non negligible rate of stroke and permanent pacemaker implantation. There is still lack of consensus on the optimal sizing method for prosthesis selection in BAV patients.\n\nThe objective of the present study is to evaluate the efficacy and safety of the LIRA sizing method in raphe-type BAV patients undergoing TAVR.",[26],[149,150,28],"LIRA method","Bicuspid aortic Valve","2025-01-02",{"date":153,"type":36},"2025-01-03",{"date":155,"type":36},"2024-12-21",{"date":157,"type":21},"2026-04-30",{"name":159,"class":43},"IRCCS San Raffaele"]