[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608089":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":27,"locations":33,"responsibleParty":50,"collaborators":23,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":23,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":23,"maxAge":23,"enrollmentInfo":61,"targetDuration":23,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":73,"whyStopped":23,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":9,"interventionNames":11},"TEER","EXPERIMENTAL",[12,13],"Device: TEER","Drug: GDMT",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","GDMT",[13],[20,24],{"type":21,"name":9,"description":9,"armGroupLabels":22,"otherNames":23},"DEVICE",[9],null,{"type":25,"name":17,"description":17,"armGroupLabels":26,"otherNames":23},"DRUG",[15,9],[28],{"name":29,"role":30,"phone":31,"phoneExt":23,"email":32},"Xiaodong Zhuang, MD","CONTACT","020-89998001","zhuangxd3@mail.sysu.edu.cn",[34],{"facility":35,"status":23,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"The First Affiliated Hospital of Sun Yat-sen University","Guangzhou","Guangdong","510080","China","CN",{"type":42,"coordinates":43},"Point",[44,45],113.25,23.11667,{"lat":45,"lon":44},[48],{"name":49,"role":30,"phone":31,"phoneExt":23,"email":32},"Xiaodong Zhuang",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Xiao-dong Zhuang","The first affiliated hospital of Sun Yat-Sen University","100608089","early-phase-1-transcatheter-edge-to-edge-repair-in-moderate-and-exertional-induced-severe-mr-timer-100608089",false,"NCT07197021","Transcatheter Edge-to-Edge Repair In Moderate and Exertional-Induced Severe MR (TIMER)","Inclusion Criteria:\n\n1. Moderate functional mitral regurgitation\n2. HG-induced severe functional mitral regurgitation\n3. Left ventricular ejection fraction (LVEF) between 20% to 50%\n4. Left ventricular end-systolic diameter (LVESD) ≤70 mm\n\nExclusion Criteria:\n\n1. Stage D heart failure per ACC\u002FAHA guidelines with hemodynamic instability or cardiogenic shock\n2. Untreated symptomatic coronary artery disease requiring revascularization\n3. Chronic obstructive pulmonary disease (COPD) requiring continuous oxygen therapy or long-term corticosteroids therapy\n4. Severe pulmonary hypertension or moderate-to-severe right ventricular dysfunction\n5. Aortic or tricuspid valve disease requiring surgical or transcatheter intervention\n6. Life expectancy \\\u003C12 months","ALL",{"count":62,"type":63},300,"ESTIMATED","INTERVENTIONAL",[66],"EARLY_PHASE1","Transcatheter Edge-to-Edge Repair (TEER) has become an established alternative for the treatment of severe mitral regurgitation (MR). RESHAPE trial indicated that patients with moderate functional MR (FMR) and heart failure (HF) might benefit from TEER. However, it still not clear that TEER is effective for which subset of patients with FMR.\n\nHand-Gripping (HG), characterized with an increased venous return, preservation or increase of left ventricular (LV) afterload and systemic vascular resistance, has been identified as a means of stress test to identify exertion-induced mitral regurgitation. Most importantly, compared to exercise stress testing via treadmill running or cycling in patients with moderate FMR, HG demonstrates significantly higher feasibility and safety.\n\nHG-induced severe MR reflects the reversibility of the regurgitation under stress, suggesting that reducing MR through TEER might alleviate LV volume overload, improve cardiac efficiency, and mitigate symptoms, which need to be validated in this trial.\n\nTIMER is a multi-center, randomized, double blind, placebo-controlled trial. A total of 300 patients with moderate and exertional-induced severe MR will be randomized in a 1:1 ratio to the treatment with TEER and guideline-directed medical therapy (GDMT) or GDMT only.\n\nThe primary endpoint of this study is rehospitalization within 24 months.",[69],"Mitral Regurgitation Functional",[71,9,72],"hand grip","moderate","NOT_YET_RECRUITING","2025-09-20",{"date":76,"type":77},"2025-09-29","ACTUAL",{"date":79,"type":63},"2025-10-01",{"date":81,"type":63},"2030-09-30",{"name":5,"class":6},1]