[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586568":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":45,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":10,"enrollmentInfo":63,"targetDuration":66,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Hospital Clínico Universitario de Valladolid","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Severe Aortic Valve Stenosis",null,"All patients with Severe Aortic Valve Stenosis undergoing TAVR using Myval Transcatheter Heart Valve",[13],"Procedure: TAVR",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","TAVR","TAVR procedure using Myval Transcatheter Heart Valve",[9],[21,27],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Ignacio J Amat-Santos, PhD","CONTACT","+34 983420000","86571","icicor@icicor.es",{"name":28,"role":23,"phone":24,"phoneExt":25,"email":26},"Carlos Baladrón, PhD",[30],{"facility":5,"status":31,"city":32,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Valladolid","47003","Spain","ES",{"type":37,"coordinates":38},"Point",[39,40],-4.72353,41.65541,{"lat":40,"lon":39},[43],{"name":44,"role":23,"phone":24,"phoneExt":25,"email":26},"Ignacio J. Amat-Santos, PhD",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Ignacio J. Amat Santos","Coordinator of Interventional Cardiology Unit",[50],{"name":51,"class":52},"Meril Life Sciences Pvt. Ltd.","INDUSTRY","100586568","mylead-spanish-prospective-registry-100586568",false,"NCT06917066","MYLEAD Spanish Prospective Registry","Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)","MYLEAD","Inclusion Criteria:\n\n* Adult patients (over 18 years of age)\n* Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.\n\nExclusion Criteria:\n\n* Patients with pre-existing permanent pacemaker.\n* Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.","ALL","18 Years",{"count":64,"type":65},500,"ESTIMATED","12 Months","OBSERVATIONAL","Investigator-initiated, prospective, multicentre registry, whose objectives are: 1\u002F to evaluate the incidence of conduction defects and the need of pacemaker implantation post-procedure, at discharge, at 30 days and at 1 year post Myval transcatheter heart valve deployment, and 2\u002F To evaluate the factors determining in-hospital and late (at 30 days and 1 year) conduction defects post Myval transcatheter heart valve.\n\nPatients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve that meet all inclusion criteria and any exclusion criteria will be able to participate in this study if they sign the informed consent. Electrocardiogram, echocardiogram and computed tomography will be performed to patients at different time points (Baseline, post-procedure, discharge, 30 days and 1 year post procedure) and their parameters will be added into a dedicated REDCAP database.",[70],"Severe Aortic Valve Stenosis",[70,17,72],"Myval Transcatheter Heart Valve","2025-04-01",{"date":75,"type":76},"2025-04-08","ACTUAL",{"date":78,"type":76},"2024-10-23",{"date":80,"type":65},"2026-12",{"name":5,"class":6},1]