[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100374974":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":62,"centralContacts":67,"locations":77,"responsibleParty":106,"collaborators":10,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":10,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":10,"studyType":121,"phases":10,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":80,"whyStopped":10,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"National Medical Research Center for Children's Health, Russian Federation","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1",null,"We will study safety, clinical and hemodynamic efficacy of the method of the aortic valve reconstruction with autopericardium in children with aortic valve disease.",[13,14,15,16,17,18,19],"Diagnostic Test: Physical examination","Diagnostic Test: The Ross Classification for Heart Failure in Children","Diagnostic Test: The Aristotle score","Other: Assessment of administered specific therapy","Diagnostic Test: Multispiral computed tomography\u002F3D echocardiography","Diagnostic Test: Transthoracic and transesophageal echocardiography","Diagnostic Test: 12-lead electrocardiogram",[21,29,35,41,46,52,56],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Physical examination","A physical examination is a routine screening procedure used to investigate a patient's symptoms or complaints. It consists of a series of questions regarding patient medical history followed by an examination of the symptoms to determine the correct diagnosis and treatment plan.",[9],[27,28],"Medical examination","Clinical examination",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"The Ross Classification for Heart Failure in Children","The assessment is performed by pediatric cardiologist according to the classic Ross scale. One of the 4 classes of chronic heart failure is registered.",[9],[34],"Assessment of heart failure according to Ross scale",{"type":22,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"The Aristotle score","Surgical risks will be assessed by the ARISTOTLE score developed specially for the task. The calculation will be performed online, available from http:\u002F\u002Fwww.aristotleinstitute.org.",[9],[40],"Assessment of surgical risks according to the ARISTOTLE score",{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"OTHER","Assessment of administered specific therapy","The data will be registered as groups of administered medicines:\n\n* Antiplatelet agents\n* Loop diuretics\n* Potassium-sparing diuretics\n* Angiotensin-converting enzyme inhibitors",[9],{"type":22,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Multispiral computed tomography\u002F3D echocardiography","All patients enrolled in the study should be routinely examined with multispiral computed tomography (MS-CT) or 3D-echo before surgery and 3 years later. As a result, a 3D aortic root reconstruction will be made to assess its size and anatomy and subsequently build a 3D soft model for surgery imitation.\n\nAt the study onset, we plan to perform MS-CT, then 3D-echo. If the correlation resulting from 3D-echo and the actual sizes will be high, the isolated 3D-echo will be preferred in the future.\n\nIf none of the methods is available, the patients will not be enrolled in the study.\n\nThe following data will be registered for further analysis:\n\n* Perimeter of the aortic valve\n* Diameter of the aortic valve at sinuses level\n* Height of the aortic sinuses\n* Morphology of the aortic valve",[9],[51],"MS-CT\u002F3D-echo",{"type":22,"name":53,"description":54,"armGroupLabels":55,"otherNames":10},"Transthoracic and transesophageal echocardiography","Transthoracic echocardiography is carried out at baseline, at discharge and then annually. It is performed in order to assess the contractile function of the heart and hemodynamic characteristics of the aortic valve and its autopericardium graft.\n\nTransesophageal echocardiography is carried out directly after the withdrawal of the artificial circulation when performing augmentation of the aortic valve with autopericardium in order to asses hemodynamic characteristics of the aortic neo-valve.",[9],{"type":22,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"12-lead electrocardiogram","Registering 12-lead electrocardiogram (ECG) is used as a tool for assessment of the regularity of the heart rhythm as well as screening and predictive tool for assessment of fibrosis and hypertrophy processes in the myocardium. The following data will be registered:\n\n* Heart rate\n* Sinus rhythm (yes\u002Fno)\n* Positive R wave in leads V5-6\n* Angle α less than 0\n* Presence\u002Fabsence of abnormal Q wave\n* Presence\u002Fabsence of ST-segment depression in precordial leads",[9],[61],"12-lead ECG",[63],{"name":64,"affiliation":65,"role":66},"Dmitry V. Ryabtsev, PhD","National Research Center of Children's Health","PRINCIPAL_INVESTIGATOR",[68,73],{"name":69,"role":70,"phone":71,"phoneExt":10,"email":72},"Vladimir P. Miroshnichenko, PhD","CONTACT","+7 499 134-04-70","miroshnichenko@nczd.ru",{"name":74,"role":70,"phone":75,"phoneExt":10,"email":76},"Alexander A. Lezhnev, PhD","+7 495 967-14-20","lezhnev.aa@nczd.ru",[78],{"facility":79,"status":80,"city":81,"state":10,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"National Medical Research Center of Children's Health","RECRUITING","Moscow","119296","Russia","RU",{"type":86,"coordinates":87},"Point",[88,89],37.61781,55.75204,{"lat":89,"lon":88},[92,96,100,102,105],{"name":93,"role":70,"phone":94,"phoneExt":10,"email":95},"Aleksandr Lezhnev, PhD, MD","+79095391010","lezhnev.md@gmail.com",{"name":97,"role":70,"phone":98,"phoneExt":10,"email":99},"Anastacia Boliguzova","+79851522773","anboliguzova@gmail.com",{"name":101,"role":66,"phone":10,"phoneExt":10,"email":10},"Dmitry Ryabtsev, PhD, MD",{"name":103,"role":104,"phone":10,"phoneExt":10,"email":10},"Vladimir Miroshnichenko","SUB_INVESTIGATOR",{"name":93,"role":104,"phone":10,"phoneExt":10,"email":10},{"type":107,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100374974","results-of-the-aortic-valve-reconstruction-in-children-100374974",false,"NCT04162444","Results of the Aortic Valve Reconstruction in Children","Short-term and Midterm Results of the Aortic Valve Reconstruction With Autopericardium in Children","Inclusion Criteria:\n\n* Age from 29 days to 12 years\n* Patient's official caregivers have to sign the informed consent after they are thoroughly explained the meaning of the study, its protocol and timelines.\n* Patients with manifestations, with mean gradient at the aortic valve \\>40 mmHg with normal left ventricular ejection fraction (LVEF), or patients with manifestations with the mean gradient \\\u003C 40 mmHg with decreased LVEF, or patients with manifestations with severe aortic insufficiency, or patients without manifestations, but with decreased LVEF with aortic insufficiency, or patients with concomitant moderate aortic insufficiency and moderate aortic stenosis with manifestations.\n* Aortic Z-score over -1,5\n* Absence of subvalvular and supravalvular aortic stenosis\n* Absence of intracardiac malformations requiring correction, except for septal defects\n\nNon-inclusion criteria:\n\n* Known hypersensitivity to aspirin, heparin, nitinol, intravenous contrast or contradictions to their administration due to other causes.\n* Previous replacement of the aortic valve with mechanical or xenografts.\n* Confirmed active sepsis or endocarditis.\n* Hypoplasia of the fibrous ring of the aortic valve with Z score under -1,5.\n* Life expectancy less than 3 years due to concomitant diseases.\n* Participation in another clinical research.\n* Indications for urgent surgery.\n* Intracardiac malformations requiring momentary surgical correction.\n* Geographical instability of a patient and his\u002Fher official caregivers, complicating significantly the constant contact during the study\n\nExclusion Criteria:\n\n• Refusal of patient's caregivers to participate further in the study.","ALL","29 Days","12 Years",{"count":119,"type":120},40,"ESTIMATED","OBSERVATIONAL","Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system. This disease requires replacement of the damaged valve which in itself is not a trivial task to complete in children as there is still no available best practice for valve replacement. Today, the following alternative variants are performed in children: mechanical aortic prosthesis, xenografts, allografts, and pulmonary autograft (Ross procedure) and each has its potential advantages and disadvantages.\n\nMechanical aortic prostheses require lifelong anticoagulation therapy and repeated surgeries to replace mechanical valves during child growth. Available xenografts in children also has suboptimal results not only because of absence of growth potential, but also due to development of degenerative changes in biological tissue of the graft leaflets. Allograft tissues are exposed to rapid biodegradation in the recipient body and thus requiring repeated surgeries associated with higher difficulty, high risk of hemorrhages, and injury of the coronary injuries. Ross procedure was proposed as theoretically the most evidence-based reconstruction of the aortic valve in children. Even successfully performed Ross operation transforms one-valve disorder into two-valve disease.\n\nThe accumulation of knowledge on the anatomy of the aortic root and improvement of surgical techniques led to the development of new methods for reconstruction of the valve function. The technique is widely applied in adult cardiac surgery, uses glutaraldehyde-treated autopericardium for augmentation of the leaflets. Absence of foreign material provides no need for anticoagulation therapy. Potentially, reconstruction of the aortic valve with autopericardium can be widely used in children.\n\nAim is to study safety, clinical and hemodynamic efficacy of the method of the aortic valve reconstruction with autopericardium in children with aortic valve disease. Patients aged 29 days to 12 years will be included into the study. The data according to the protocol of the study will be assessed at the stage of inclusion, during the surgery, in 30 days after the surgery, and in 1, 2, and 3 years after the surgery. Data about all the patients included into the research will be analyzed in order to study the endpoints and achieve the research aim.",[124],"Aortic Valve Insufficiency",[126,127,128,129,130,131,132,133,134,135],"Aortic Valve Insufficiency\u002Fsurgery","Aortic Valve\u002Fsurgery","Child","Reconstructive Surgical Procedures\u002Fmethods","Cardiac Surgical Procedures","Hemodynamics","Pericardium\u002Ftransplantation","Transplantation, Autologous","Treatment Outcome","Heart Valve Prosthesis Implantation","2021-03-02",{"date":138,"type":139},"2021-03-03","ACTUAL",{"date":141,"type":139},"2020-02-18",{"date":143,"type":120},"2027-10",{"name":5,"class":6},1]