[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416517":3},{"organization":4,"outcomesModule":7,"designInfo":107,"detailedDescription":110,"studyPopulation":111,"armGroups":19,"interventions":112,"overallOfficials":119,"centralContacts":124,"locations":130,"responsibleParty":259,"collaborators":19,"id":261,"slug":19,"hasResults":262,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":19,"eligibilityCriteria":266,"healthyVolunteers":262,"sex":267,"minAge":268,"maxAge":19,"enrollmentInfo":269,"targetDuration":19,"studyType":272,"phases":19,"briefSummary":273,"conditions":274,"keywords":19,"overallStatus":133,"whyStopped":19,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},{"fullName":5,"class":6},"Meril Life Sciences Pvt. Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":19},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3)","It is the composite of following\n\n* All-cause mortality\n* All stroke (disabling and non-disabling)\n* Life-threatening or disabling bleeding\n* Acute kidney injury (stage 2 or 3)\n* Major vascular complications\n* Moderate or severe prosthetic valve regurgitation\n* Conduction system disturbances resulting in a new permanent pacemaker implantation","30 day",[14,17,21,24,27,29,32,35,39,43,46,49,53,56,60,64,67,71,74,78,81,84,88,91,95,98,101,104],{"measure":15,"description":16,"timeFrame":12},"All-cause mortality","Number of mortality as per VARC - 3 Criteria",{"measure":18,"description":19,"timeFrame":20},"All stroke",null,"Through 30 days",{"measure":22,"description":23,"timeFrame":20},"Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4","Number of participants of AKI as per AKIN Network",{"measure":25,"description":26,"timeFrame":20},"Bleeding type 3 and 4","Number of participants for bleeding as per VARC-3 criteria",{"measure":28,"description":19,"timeFrame":20},"Moderate or severe prosthetic valve regurgitation",{"measure":30,"description":31,"timeFrame":20},"New permanent pacemaker implantation","New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and\u002For right bundle branch block",{"measure":33,"description":34,"timeFrame":20},"Conduction disturbances and arrhythmias","Number of participants for Conduction disturbances and arrhythmias as per VARC-3 Criteria",{"measure":36,"description":37,"timeFrame":38},"Device Success","Number of participants for Device success as per VARC-3 Criteria","During hospital stay or maximum of 7 days after index procedure, whichever is earlier.",{"measure":40,"description":41,"timeFrame":42},"Early safety at 30 days","Number of participants for Early safety as per VARC-3 Criteria","After 30 days of index procedure",{"measure":44,"description":45,"timeFrame":42},"Clinical efficacy after 30 days","Number of participants for Clinical efficacy as per VARC-2 Criteria",{"measure":47,"description":48,"timeFrame":20},"Time related valve safety","Number of participants for Time related valve safety as per VARC-2 Criteria",{"measure":50,"description":51,"timeFrame":52},"Vascular and access related complications","Number of participants for Vascular and access related complications as per VARC-3 Criteria","Pre-discharge, Through 30 days",{"measure":54,"description":55,"timeFrame":52},"Major vascular complications","Number of participants for Major vascular complications as per VARC-3 Criteria",{"measure":57,"description":58,"timeFrame":59},"Functional improvement from baseline as measured","Number of participants for Functional improvement as per NYHA functional classification","Baseline, 30 days",{"measure":61,"description":62,"timeFrame":63},"Echocardiographic End Points","* Effective orifice area (EOA)\n* Index effective orifice area (iEOA)\n* Mean aortic valve gradient\n* Peak aortic valve gradient\n* Peak aortic velocity\n* Transvalvular, paravalvular and total aortic regurgitation\n* Left ventricular ejection fraction (LVEF)\n* Valve calcification\n* Cardiac output and cardiac index","Through 30 days]",{"measure":65,"description":66,"timeFrame":20},"Patient-prosthesis Mismatch","Severity patient-prosthesis-mismatch will be based on following For subjects with BMI \\\u003C 30 kg\u002Fm2, index effective orifice area (EOAi) 0.85 - 0.66 cm2\u002Fm2 for moderate and ≤0.65 cm2\u002Fm2 for severe For subjects with BMI ≥30 kg\u002Fm2, index effective orifice area (EOAi) 0.70 - 0.56 cm2 \u002Fm2 for moderate and ≤0.55 cm2\u002Fm2 for severe BMI = weight(kg)\u002F(height (m)) 2",{"measure":68,"description":69,"timeFrame":70},"Length of index hospital stay","Number of days from hospital admission to discharge","At discharge",{"measure":72,"description":73,"timeFrame":20},"Re-hospitalization","Number of participants as per VARC-3 defined criteria",{"measure":75,"description":76,"timeFrame":77},"New onset of atrial fibrillation or atrial flutter","VARC-3 criteria","Post-procedure, Pre-discharge and 30 days",{"measure":79,"description":80,"timeFrame":20},"Endocarditis","Number of participants for Endocarditis as per VARC-3 criteria",{"measure":82,"description":83,"timeFrame":20},"Major bleeding event","Number of participants for Major bleeding event as per VARC-3 criteria",{"measure":85,"description":86,"timeFrame":87},"Myocardial rupture","Number of participants for Myocardial rupture","During procedure",{"measure":89,"description":90,"timeFrame":20},"Paravalvular Leak","Number of participants for Paravalvular Leak",{"measure":92,"description":93,"timeFrame":94},"Degree of over - or Under-expansion of Myval","Number of participants for Degree of over - or Under-expansion of Myval","During Procedure",{"measure":96,"description":97,"timeFrame":87},"Accuracy of deployment in relation to the annular plane","Number of participants for Accuracy of deployment in relation to the annular plane",{"measure":99,"description":100,"timeFrame":20},"Pacemaker deployment (and the symptoms resulting in it)","Number of participants for Pacemaker deployment (and the symptoms resulting in it)",{"measure":102,"description":103,"timeFrame":87},"Interference with the mitral valve","Number of participants for Interference with the mitral valve",{"measure":105,"description":106,"timeFrame":87},"Interference with the LVOT","Number of participants for Interference with the LVOT",{"allocation":19,"interventionModel":19,"interventionModelDescription":19,"primaryPurpose":19,"observationalModel":108,"timePerspective":109,"maskingInfo":19},"CASE_ONLY","RETROSPECTIVE","Myval Global Study: A retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.\n\nThis study shall retrospectively collect the data of minimal 200 consecutive patients treated with Myval™ THV Series approximately 15 participating sites Globally.\n\nPrimary Endpoint:\n\nPrimary Combined Safety and Effectiveness Endpoint: \\[Time frame: 30 days\\]\n\nIt is the composite of following:\n\n* All-cause mortality\n* All stroke\n* Bleeding (type 3 and 4)\n* Acute kidney injury (stage 2 ,3 \\& 4)\n* Major vascular complications\n* Moderate or severe prosthetic valve regurgitation\n* Conduction system disturbances resulting in a new permanent pacemaker implantation.\n\nSecondary endpoints:\n\n1. All-cause mortality (VARC-3 defined criteria) \\[Time Frame: Through 30 days\\]\n2. All stroke (VARC-3 defined criteria) \\[Time Frame: Through 30 days\\]\n3. Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4 \\[Time Frame: Through 30 days\\]\n4. Bleeding type 3 and 4 (VARC-3 criteria) \\[Time Frame: Through 30 days\\]\n5. Moderate or severe prosthetic valve regurgitation \\[Time Frame: Through 30 days\\]\n6. New permanent pacemaker implantation \\[Time Frame: Through 30 days\\] New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and\u002For right bundle branch block.\n7. Conduction disturbances and arrhythmias according to VARC-3 \\[Time Frame: Through 30 days\\]\n8. Device success (VARC-3 criteria) \\[Time Frame: Pre-discharge\\]\n9. Early safety at 30 days (VARC-3 criteria) \\[Time Frame: After 30 days of index procedure\\]\n10. Clinical efficacy after 30 days (VARC-2 criteria) \\[Time Frame: After 30 days of index procedure\\]\n11. Time-related valve safety (VARC-2 criteria) \\[Time Frame: Through 30 days\\]\n12. Vascular and access related complications (VARC-3 criteria) \\[Time Frame: Pre-discharge, Through 30 days\\]\n13. Major vascular complications (VARC-3 criteria) \\[Time Frame: Pre-discharge, Through 30 days\\]\n14. Functional improvement from baseline as measured per\n\n    a. NYHA functional classification \\[Time frame: Baseline, 30 days\\]\n15. Echocardiographic End Points\n\n    * Effective orifice area (EOA)\n    * Index effective orifice area (iEOA)\n    * Mean aortic valve gradient\n    * Peak aortic valve gradient\n    * Peak aortic velocity\n    * Transvalvular, paravalvular and total aortic regurgitation\n    * Left ventricular ejection fraction (LVEF)\n    * Valve calcification\n    * Cardiac output and cardiac index \\[Time frame: Through 30 days\\]\n16. Patient-prosthesis Mismatch: \\[Time Frame: Post-procedure, predishcarge, Through 30 days\\] Severity patient-prosthesis-mismatch will be based on following\n\n    * For subjects with BMI \\\u003C 30 kg\u002Fm2, index effective orifice area (EOAi) 0.85 - 0.66 cm2 \u002Fm2 for moderate and ≤0.65 cm2 \u002Fm2 for severe\n    * For subjects with BMI ≥30 kg\u002Fm2, index effective orifice area (EOAi) 0.70 - 0.56 cm2 \u002Fm2 for moderate and ≤0.55 cm2 \u002Fm2 for severe BMI = weight(kg)\u002F(height (m)) 2\n17. Length of index hospital stay. \\[Time frame: At discharge\\]\n\n    \\- Number of days from hospital admission to discharge.\n18. Re-hospitalization (VARC-3 defined criteria) \\[Time Frame: Through 30 days\\]\n19. New onset of atrial fibrillation or atrial flutter \\[Time Frame: Post-procedure, Pre-discharge and 30 days\\]\n20. Endocarditis \\[Time Frame: Through 30 days\\]\n21. Major bleeding event \\[Time Frame: Through 30 days\\]\n22. Other Endpoints:\n\n    * Myocardial rupture \\[Time Frame: During procedure\\]\n    * Paravalvular leak \\[Time Frame:Through 30 days\\]\n    * Degree of over- or under-expansion of Myval \\[Time Frame: During procedure\\]\n    * Accuracy of deployment in relation to the annular plane \\[Time Frame: During procedure\\]\n    * Pacemaker deployment (and the symptoms resulting in it) \\[Time Frame: Through 30 days\\]\n    * Interference with the mitral valve; and \\[Time Frame: During procedure\\]\n    * Interference with the LVOT \\[Time Frame: During procedure\\]\n\n      * If the endpoint data is available through 1 year, it will also be collected and analyzed.\n\nClinical efficacy data will be collected only for patients with availability of data after 30 days follow-up.\n\nLong term clinical follow up by telephonic interview will be conducted for all patients who have completed 30 days safety follow-up, at 1 year, 3 year and 5 years.","All patients who have been treated with Myval™ THV series will be selected for the study.",[113],{"type":114,"name":115,"description":116,"armGroupLabels":19,"otherNames":117},"DEVICE","Myval Transcatheter Heart Valve Series","Myval™ THV is a newer-generation balloon-expandable THV characterized by a nickel-cobalt alloy frame composed of a single element - hexagon arranged in a hybrid honeycomb fashion.",[118],"Myval THV",[120],{"name":121,"affiliation":122,"role":123},"Ashok Thakkar, Ph.D.","Head - Clinical Research and Medical Writing","STUDY_CHAIR",[125],{"name":121,"role":126,"phone":127,"phoneExt":128,"email":129},"CONTACT","+91-260-3063880","242","Ashok.Thakkar@merillife.com",[131,147,163,183,200,214,230,246],{"facility":132,"status":133,"city":134,"state":19,"zip":19,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":142,"contacts":143},"North Estonia Medical center","RECRUITING","Tallinn","Estonia","EE",{"type":138,"coordinates":139},"Point",[140,141],24.75353,59.43696,{"lat":141,"lon":140},[144],{"name":145,"role":126,"phone":19,"phoneExt":19,"email":146},"Dr. Peep Laanmets","peep.laanmets@regionaalhaigla.ee",{"facility":148,"status":133,"city":149,"state":19,"zip":150,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Clinical Institute Saint Ambrogio","Milan","20149","Italy","IT",{"type":138,"coordinates":154},[155,156],12.59836,42.78235,{"lat":156,"lon":155},[159],{"name":160,"role":126,"phone":161,"phoneExt":19,"email":162},"Dr. Alfonso Ielasi, MD","+39 338 8433189","alielasi@hotmail.com",{"facility":164,"status":133,"city":165,"state":166,"zip":167,"country":168,"countryCode":169,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Amphia Ziekenhui","Breda","North Brabant","4818","Netherlands","NL",{"type":138,"coordinates":171},[172,173],4.77596,51.58656,{"lat":173,"lon":172},[176,180],{"name":177,"role":126,"phone":178,"phoneExt":19,"email":179},"Dr. A. J. J. IJsselmuiden, MD, Ph.D","+31(0)655814502","siisselmuiden@amphia.nl",{"name":181,"role":182,"phone":19,"phoneExt":19,"email":19},"Simsek Cihan, Ph.D","SUB_INVESTIGATOR",{"facility":184,"status":133,"city":185,"state":186,"zip":187,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"University of Gdansk","Gdansk","Bażyńskiego","80-309","Poland","PL",{"type":138,"coordinates":191},[192,193],18.64912,54.35227,{"lat":193,"lon":192},[196],{"name":197,"role":126,"phone":198,"phoneExt":19,"email":199},"Prof. Dariusz Jagielak, MD, PhD","+48509487577","darjag@gumed.edu.pl",{"facility":201,"status":133,"city":202,"state":19,"zip":19,"country":203,"countryCode":204,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"University Medical Centre Ljubljana","Ljubljana","Slovenia","SI",{"type":138,"coordinates":206},[207,208],14.50513,46.05108,{"lat":208,"lon":207},[211],{"name":212,"role":126,"phone":19,"phoneExt":19,"email":213},"Prof. Matjaz Bunc","matjaz.bunc@kclj.si",{"facility":215,"status":133,"city":216,"state":19,"zip":217,"country":218,"countryCode":219,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Hospital Universitario de Gran Canaria Dr. Negrin","Las Palmas de Gran Canaria","35010","Spain","ES",{"type":138,"coordinates":221},[222,223],-15.41573,28.10178,{"lat":223,"lon":222},[226],{"name":227,"role":126,"phone":228,"phoneExt":19,"email":229},"Dr. Pedro Martin Lorenzo","+34 616 129540 \u002F 928 284105","pemarlor@hotmail.com",{"facility":231,"status":133,"city":232,"state":19,"zip":233,"country":218,"countryCode":219,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Hospital Cliinico Univertistario de Valladolid","Valladolid","47003",{"type":138,"coordinates":235},[236,237],-4.72353,41.65541,{"lat":237,"lon":236},[240,244],{"name":241,"role":126,"phone":242,"phoneExt":19,"email":243},"Dr. Ignacio A Santos, Medicine & Surgery","+34657923040","ijamat@gmail.com",{"name":245,"role":182,"phone":19,"phoneExt":19,"email":19},"Jose R Delgado Arana, Medicine",{"facility":247,"status":133,"city":248,"state":19,"zip":19,"country":249,"countryCode":19,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"Kocaeli University School of Medicine","Kocaeli","Turkey (Türkiye)",{"type":138,"coordinates":251},[252,253],27.51145,39.62497,{"lat":253,"lon":252},[256],{"name":257,"role":126,"phone":19,"phoneExt":19,"email":258},"Prof. Teoman Kilic","kilicteoman@yahoo.com",{"type":260,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100416517",false,"NCT04703699","Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.","A Retrospective, Multinational, Multicentre, Observational Study in Patients Presenting With Native Severe Aortic Valve Stenosis and Treated With Myval™ Transcatheter Heart Valve Series in Real-world Setting.","Inclusion Criteria:\n\n* All patients of this study must have received Myval™ THV series for treatment of native severe aortic stenosis and completed a minimum of 30-day follow-up.\n\nExclusion Criteria:\n\n* No","ALL","18 Years",{"count":270,"type":271},200,"ESTIMATED","OBSERVATIONAL","A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.",[275],"Aortic Valve Stenosis","2024-02-29",{"date":278,"type":279},"2024-03-04","ACTUAL",{"date":281,"type":279},"2020-08-07",{"date":283,"type":271},"2028-11-30",{"name":5,"class":6},8]