[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xiao-dong Zhuang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100578662","cap-teer-cerebral-protection-during-transcatheter-edge-to-edge-repair-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":18,"type":19},120,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25,26,27],"Mitral Regurgitation","Functional Mitral Regurgitation","Degenerative Mitral Valve Regurgitation","NOT_YET_RECRUITING","2025-02-05",{"date":31,"type":32},"2025-02-07","ACTUAL",{"date":34,"type":19},"2025-03-01",{"date":36,"type":19},"2025-10-31",{"name":38,"class":39},"Xiao-dong Zhuang","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":68,"locationsCount":40},"100574658","phase-4-early-effect-of-glucocorticoid-on-incidence-of-persistent-left-bundle-branch-block-lbbb-post-tavr-eagle-tavr-trial-100574658","NCT06762145","EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR (EAGLE-TAVR Trial)","EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR","EAGLE-TAVR","Inclusion Criteria:\n\n1. Age ≥ 65 years\n2. Selected to undergo transfemoral TAVR based on heart team decision\n\nExclusion Criteria:\n\n1. Allergic to Methylprednisolone\n2. Patients with a prior pacemaker or high degree atrioventricular block\n3. Septicemia\n4. Life expectancy \\\u003C 1 year irrespective of heart disease (Cancer, severe liver disease, severe renal disease, severe pulmonary, et al)\n5. Inability to provide written informed consent\n6. Participation in another clinical trial with an active intervention\n7. Patients on prior chronic treatment with glucocorticoids (both oral, inhaled, or intravenous, but topical and ophthalmic administration is allowed)\n8. Gastrointestinal bleeding\n9. Acute myocardial infarction within 1 month\n10. Intracardiac thrombus or vegetation","65 Years",{"count":51,"type":19},200,[53],"PHASE4","Transcatheter aortic valve replacement (TAVR) has become an established alternative for the treatment of severe symptomatic aortic stenosis irrespective of surgical risk. The development of new-onset left bundle branch block (LBBB) is the most common complication, which impairs outcomes after TAVR.\n\nGlucocorticoid has been proven safe and effective in arrythmia after cardiac surgery. The anti-inflammatory effect of glucocorticoid may alleviate the occurrence of LBBB and thus the prognosis.\n\nEAGLE-TAVR is a multi-center, randomized, double blind, placebo-controlled trial. A total of 200 patients selected to undergo TAVR will be randomized in a 1:1 ratio to the treatment with intravenous Methylprednisolone 1mg\u002Fkg\u002Fday or placebo for 3 days started from the day of the procedure.\n\nAccording to the definition of the Valve Academic Research Consortium 3, persistent LBBB is defined as present LBBB at discharge or \\>7 days post-TAVR. The primary endpoint is the occurrence of new-onset LBBB at 30 days post TAVR.",[56,57],"Transcatheter Aortic Valve Replacemen","Left Bundle Branch Block",[59,60,61],"TAVR","LBBB","Glucocorticoid","2025-01-01",{"date":64,"type":32},"2025-01-07",{"date":62,"type":19},{"date":67,"type":19},"2025-07-31",{"name":38,"class":39},""]