[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632128":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":47,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":10,"maxAge":10,"enrollmentInfo":58,"targetDuration":10,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Subjects who receive TriClip procedure with TriClip System",null,"The subjects from the general Japanese population are scheduled to undergo the TriClip procedure with commercially approved TriClip System per the current Japan Indication for Use (IFU).",[13],"Device: The TriClip System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","The TriClip System","The TriClip System procedure will be performed in accordance with the Indication for Use (IFU) in Japan. The TriClip System is a transcatheter tricuspid valve repair system used to facilitate transcatheter edge-to-edge repair of the tricuspid valve leaflets and designed to deliver and deploy the Clip",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Jacob Zbinden","CONTACT","+16517564272","jacob.zbinden@abbott.com",{"name":27,"role":23,"phone":10,"phoneExt":10,"email":28},"Meghan Griffin","meghan.griffin@abbott.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"National Cerebral & Cardiovascular Center Hospital","RECRUITING","Suita","Osaka","564-8565","Japan","JP",{"type":39,"coordinates":40},"Point",[41,42],135.51567,34.76143,{"lat":42,"lon":41},[45],{"name":46,"role":23,"phone":10,"phoneExt":10,"email":10},"Chisato Izumi",{"type":48,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100632128","triclip-japan-post-approval-study-100632128",false,"NCT07509658","TriClip Japan Post-Approval Study","A Prospective, Single-arm, Multi-center, Observational, Post-approval Study Designed to Confirm the Safety and Efficacy of the TriClip System in Japan.","TriClip JP PAS","Inclusion Criteria:\n\n* Subjects are eligible to receive the TriClip System per the current approved indications for use (IFU)\n* Subjects provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.\n\nExclusion Criteria:\n\n* There are no exclusion criteria\n* Please note: It is not recommended that subjects enrolled in the study participate in any other therapeutic clinical study.","ALL",{"count":59,"type":60},250,"ESTIMATED","OBSERVATIONAL","The goal of this observational post approval study is to confirm the safety and efficacy of the TriClip System when used in routine clinical practice in the Japanese population and to fulfill post-market requirements following commercial approval in Japan.",[64],"Tricuspid Regurgitation",[66,64,67],"TR","TriClip","2026-03-31",{"date":70,"type":71},"2026-04-03","ACTUAL",{"date":73,"type":71},"2026-03-02",{"date":75,"type":60},"2029-12-15",{"name":5,"class":6},1]