[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534638":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":58,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":18,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Columbia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CardioMems","EXPERIMENTAL","Participants randomized to this arm will receive hemodynamic-guided GDMT titration with CardioMems.",[13],"Device: CardioMEMS",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","Participants randomized to this arm will receive usual care involving GDMT.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","CardioMEMS","Hemodynamic-guided optimization will be performed using the CardioMEMS CardioClip device.",[9],[26,29],{"name":27,"affiliation":5,"role":28},"Nir Uriel, MD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"Michael Brener, MD",[32],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Kate Dalton, MS, RD, CCRC","CONTACT","(347) 514-3366","keb2114@cumc.columbia.edu",[38],{"facility":39,"status":40,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Columbia University Irving Medical Center \u002F NewYork-Presbyterian Hospital","RECRUITING","New York","10032","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-74.00597,40.71427,{"lat":49,"lon":48},[52,53,54],{"name":33,"role":34,"phone":18,"phoneExt":18,"email":36},{"name":27,"role":28,"phone":18,"phoneExt":18,"email":18},{"name":30,"role":28,"phone":18,"phoneExt":18,"email":18},{"type":28,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Nir Uriel","Seymour, Paul, and Gloria Milstein Professor of Cardiology",[59,62],{"name":60,"class":61},"Abbott","INDUSTRY",{"name":63,"class":64},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100534638","the-cardioclip-study-100534638",false,"NCT06241430","The CardioClip Study","Hemodynamic-Guided Optimization With the CardioMEMS Device of Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Mitral Transcatheter Edge-to-Edge Repair With the MitraClip Device","CardioClip","Inclusion Criteria:\n\n* Significant (moderate-severe \\[3+\\] or severe \\[4+\\] secondary MR)\n* Left ventricular dysfunction (ejection fraction \\>20% and \\\u003C50%)\n* New York Heart Association (NYHA) class II-IVa symptoms\n* Sign informed consent to participate in the study\n\nExclusion Criteria:\n\n* Left ventricular (LV) end-systolic dimension 70 mm\n* PA systolic pressure 70 mmHg (fixed)\n* Mitral valve (MV) orifice area \\\u003C4.0 cm2\n* Commissural MR jet or leaflet anatomy not suitable for mTEER\n* Likely to undergo heart transplantation or LV assist device implantation in the next 12 months\n* Recurrent (i.e., \\>1) pulmonary embolism or deep vein thrombosis\n* Complex congenital heart disease\n* Mechanical right heart valve (tricuspid or pulmonic)\n* Cardiac resynchronization therapy implanted within 3 months of enrollment\n* Hypersensitivity to aspirin and\u002For clopidogrel\n* History of medication non-adherence","ALL","18 Years","90 Years",{"count":77,"type":78},60,"ESTIMATED","INTERVENTIONAL",[81],"NA","The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.",[84,85],"Heart Failure With Reduced Ejection Fraction","Mitral Regurgitation",[87,88,89,90,91,92,93,94,95,96],"Heart failure","Reduced ejection fraction","Mitral regurgitation","mTEER (mitral transcatheter edge-to-edge repair)","CardioMems (implantable pulmonary artery pressure sensor)","Guideline-directed medical therapy (GDMT)","HF hospitalization (HFH)","Clinical trial","Hemodynamic monitoring","Cardiovascular outcomes","2026-06-25",{"date":99,"type":100},"2026-06-29","ACTUAL",{"date":102,"type":100},"2024-12-18",{"date":104,"type":78},"2030-06",{"name":5,"class":6},1]