[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578662":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":23,"locations":29,"responsibleParty":45,"collaborators":18,"id":49,"slug":18,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":18,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":55,"maxAge":18,"enrollmentInfo":56,"targetDuration":18,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":18,"overallStatus":67,"whyStopped":18,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cerebral Embolic Protection","EXPERIMENTAL","Subjects will undergo M-TEER following placement of the cerebral embolic protection device.",[13],"Device: Cerebral Embolic Protection",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Subjects will undergo M-TEER without cerebral embolic protection device.",null,[20],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":18},"DEVICE",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Xiao-dong Zhuang MD","CONTACT","+8613760755035","zhuangxd3@mail.sysu.edu.cn",[30],{"facility":31,"status":18,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"The First Affiliated Hospital of Sun Yat-sen University","Guangzhou","Guangdong","510080","China","CN",{"type":38,"coordinates":39},"Point",[40,41],113.25,23.11667,{"lat":41,"lon":40},[44],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Xiao-dong Zhuang","Dr.","100578662",false,"NCT06814210","CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair","Inclusion Criteria:\n\nSubjects must meet ALL of the following criteria:\n\nGeneral Inclusion Criteria\n\n* Age ≥18 years\n* Severe Mitral Regurgitation (3+ to 4+)\n* Symptom status: NYHA functional class ≥ II\n* Subjects scheduled to receive the M-TEER per the current approved indications for use\n* Subjects agreed to join the study and complete follow-up\n\nExclusion Criteria:\n\nPotential Subjects will be excluded if ANY of the following criteria apply:\n\nGeneral Exclusion Criteria\n\n* Contraindication to MRI\n* CABG, PCI, TAVR, CRT or CRT-D within the prior 30 days\n* Aortic or tricuspid valve disease requiring surgery or transcatheter intervention\n* COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use\n* Cerebrovascular accident within prior 30 days\n* Severe symptomatic carotid stenosis (\\>70% by ultrasound)\n* Carotid surgery or stenting within prior 30 days\n* Hemodynamic instability requiring inotropic support or mechanical heart assistance\n* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.\n* Contraindication for transesophageal echocardiography\n* Life expectancy \\\u003C 1 year\n* Pregnant or planning pregnancy within next 12 months\n* Participation in another interventional Trial\n* Patients who are not able to give consent or complete the follow-up","ALL","18 Years",{"count":57,"type":58},120,"ESTIMATED","INTERVENTIONAL",[61],"NA","Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. However, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices.\n\nThis prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected M-TEER.",[64,65,66],"Mitral Regurgitation","Functional Mitral Regurgitation","Degenerative Mitral Valve Regurgitation","NOT_YET_RECRUITING","2025-02-05",{"date":70,"type":71},"2025-02-07","ACTUAL",{"date":73,"type":58},"2025-03-01",{"date":75,"type":58},"2025-10-31",{"name":47,"class":6},1]