[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transcatheter-mitral-valve-edge-to-edge-repair-system\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transcatheter-mitral-valve-edge-to-edge-repair-system":26},{"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":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100658134","active-surveillance-and-safetyefficacy-evaluation-of-innovative-devices-for-structural-heart-disease-intervention-100658134",false,"NCT07848152","Active Surveillance and Safety\u002FEfficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention","Establishment of Active Surveillance and Safety and Efficacy Evaluation Indicators for Innovative Devices Used in Interventional Treatment of Structural Heart Disease","ASSEE-SHD","Inclusion Criteria:\n\n1. Patients undergoing implantation of a biodegradable PFO closure device.\n2. Patients undergoing transcatheter mitral valve edge-to-edge repair.\n\nExclusion Criteria:\n\nThe participant expresses a desire to withdraw from the study.","ALL","18 Years",{"count":20,"type":21},2200,"ESTIMATED","12 Months","OBSERVATIONAL","This study aims to establish an active surveillance system to evaluate the safety and effectiveness of innovative medical devices used in the interventional treatment of structural heart disease. The devices of interest include a biodegradable patent foramen ovale (PFO) closure device and a transcatheter mitral valve edge-to-edge repair system. Clinical information from patients receiving these devices during routine clinical care will be collected and analyzed. The findings will help evaluate the safety and effectiveness of these devices and support the development of appropriate clinical evaluation indicators and long-term monitoring strategies.",[26,27],"Transcatheter Mitral Valve Edge-to-Edge Repair System","Biodegradable Patent Foramen Ovale Closure Device",[29,30],"Patent Foramen Ovale Closure Device","Transcatheter Mitral Valve Edge-to-Edge Repair","RECRUITING","2026-09-26",{"date":34,"type":35},"2026-09-29","ACTUAL",{"date":37,"type":35},"2025-12-30",{"date":39,"type":21},"2029-01-31",{"name":41,"class":42},"Shanghai Jiao Tong University School of Medicine","OTHER",11]