[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vsd---muscular-ventricular-septal-defect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vsd---muscular-ventricular-septal-defect":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":29,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100561461","abbott-structural-heart-device-registry-100561461",false,"NCT06590467","Abbott Structural Heart Device Registry","SH-Registry","Inclusion Criteria:\n\n1. Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.\n2. Subject is willing and able to comply with the site's standard of care follow-up schedule.\n3. Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC\u002FIRB recommendations regarding consent and the protection of personal data must be followed.\n\nExclusion Criteria:\n\n1\\. Subject is participating in another clinical study that would affect the results of this Registry.","ALL",{"count":18,"type":19},2500,"ESTIMATED","OBSERVATIONAL","The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017\u002F745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.",[23,24,25,26,27,28],"Heart Diseases","ASD - Atrial Septal Defect","VSD - Muscular Ventricular Septal Defect","PFO - Patent Foramen Ovale","PIVSD - Post Infarct Muscular Ventricular Septal Defect","Valvular Heart Disease",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48],"Amplatzer","Amplatzer Septal Occluder","Amplatzer Multi-fenestrated (Cribriform) Occluder","Amplatzer Duct Occluder","Amplatzer Piccolo Occluder","Amplatzer Muscular VSD Occluder","Amplatzer Post-Infarct VSD Occluder","Amplatzer Talisman","Amplatzer TorqVue Delivery System","Amplatzer Sizing Balloon","Amplatzer Guidewire","Amplatzer Occluder devices","Surgical Valves","Epic Plus Aortic Valve","Epic Plus Mitral Valve","Epic Plus Supra Aortic Valve","Epic Max Aortic Valve","Bioprosthetic heart valve","Surgical tissue heart valve","RECRUITING","2026-04-07",{"date":52,"type":53},"2026-04-13","ACTUAL",{"date":55,"type":53},"2024-08-21",{"date":57,"type":19},"2039-11",{"name":59,"class":60},"Abbott Medical Devices","INDUSTRY",28]