[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637625":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":64,"studyPopulation":65,"armGroups":66,"interventions":62,"overallOfficials":62,"centralContacts":73,"locations":79,"responsibleParty":96,"collaborators":100,"id":104,"slug":62,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":62,"enrollmentInfo":113,"targetDuration":62,"studyType":116,"phases":62,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":82,"whyStopped":62,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Cedars-Sinai Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":46},[9],{"measure":10,"description":10,"timeFrame":11},"Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention","From procedure to 3 years after procedure",[13,17,20,23,27,30,33,36,40,43],{"measure":14,"description":15,"timeFrame":16},"Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography","Percentage of participants with residual mitral regurgitation greater than 2+ assessed by transthoracic echocardiography after surgical mitral valve repair or transcatheter edge-to-edge repair.","At 30 days, 6 months, and 1 year after procedure",{"measure":18,"description":19,"timeFrame":16},"Left Ventricular Ejection Fraction by Transthoracic Echocardiography","Left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.",{"measure":21,"description":22,"timeFrame":16},"Mean Mitral Valve Gradient by Transthoracic Echocardiography","Mean transmitral valve gradient, measured in mm Hg by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.",{"measure":24,"description":25,"timeFrame":26},"Kansas City Cardiomyopathy Questionnaire Overall Summary Score","Kansas City Cardiomyopathy Questionnaire overall summary score, measured on a 0 to 100 scale, will be used to assess patient-reported health status after surgical mitral valve repair or transcatheter edge-to-edge repair. Higher scores indicate better health status.","At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure",{"measure":28,"description":29,"timeFrame":26},"Six-Minute Walk Test Distance","Functional capacity will be assessed using the 6-minute walk test distance, measured in meters.",{"measure":31,"description":32,"timeFrame":26},"SF-36 Physical Component Summary Score","The SF-36 Physical Component Summary score will be used to assess patient-reported physical health status. Scores are reported as scale scores, with higher scores indicating better physical health status.",{"measure":34,"description":35,"timeFrame":26},"SF-36 Mental Component Summary Score","The SF-36 Mental Component Summary score will be used to assess patient-reported mental health status. Higher scores indicate better mental health status.",{"measure":37,"description":38,"timeFrame":39},"Percentage of Participants With All-Cause Mortality","Percentage of participants with all-cause mortality after surgical mitral valve repair or transcatheter edge-to-edge repair.","At 30 days, 6 months, 1 year, and 5 years after procedure",{"measure":41,"description":42,"timeFrame":39},"Percentage of Participants With Heart Failure Hospitalization","Percentage of participants hospitalized for heart failure after surgical mitral valve repair or transcatheter edge-to-edge repair.",{"measure":44,"description":45,"timeFrame":39},"Mitral Valve Reintervention","Percentage of participants requiring mitral valve reintervention after surgical mitral valve repair or transcatheter edge-to-edge repair.",[47,51,55,58],{"measure":48,"description":49,"timeFrame":50},"Percentage of Participants With One or More Major Periprocedural or 30-Day Complications","Percentage of participants with one or more major periprocedural or 30-day complications after surgical mitral valve repair or transcatheter edge-to-edge repair. Major complications include coronary obstruction, cardiac tamponade, new left bundle branch block, major bleeding, stroke or transient ischemic attack, myocardial infarction, acute kidney injury, new-onset atrial fibrillation, infection or sepsis, permanent pacemaker implantation, or conversion to open surgery.","From start of procedure to 30 days after procedure",{"measure":52,"description":53,"timeFrame":54},"Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular Ejection Fraction","Correlation between baseline myocardial extracellular volume, measured as percentage extracellular volume by cardiovascular magnetic resonance imaging, and left ventricular ejection fraction, measured as percentage by transthoracic echocardiography at 6 months after procedure.","From baseline CMR to 6 months after procedure",{"measure":56,"description":57,"timeFrame":54},"Difference in 6-Month Left Ventricular Ejection Fraction by Baseline Late Gadolinium Enhancement Presence","Difference in 6-month left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, between participants with and without baseline late gadolinium enhancement on cardiovascular magnetic resonance imaging.",{"measure":59,"description":60,"timeFrame":54},"Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular End-Systolic Volume Index","Correlation between baseline myocardial extracellular volume, measured as percentage extracellular volume by cardiovascular magnetic resonance imaging, and left ventricular end-systolic volume index, measured in mL\u002Fm² by cardiovascular magnetic resonance imaging at 6 months after procedure.",{"allocation":62,"interventionModel":62,"interventionModelDescription":62,"primaryPurpose":62,"observationalModel":63,"timePerspective":6,"maskingInfo":62},null,"COHORT","This is an ambispective, (prospective and retrospective) cohort study collecting clinical, procedural, and follow-up data to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term.","The study population includes adult patients with severe degenerative mitral regurgitation (DMR) who underwent either surgical mitral valve repair or transcatheter edge-to-edge repair (TEER).",[67,70],{"label":68,"type":62,"description":69,"interventionNames":62},"Surgical mitral repair","This cohort includes patients who underwent surgical mitral valve repair for severe degenerative mitral regurgitation (DMR). The intervention involves standard surgical techniques to repair the mitral valve, aiming to restore its physiological function and reduce mitral regurgitation.",{"label":71,"type":62,"description":72,"interventionNames":62},"Transcatheter mitral edge-to-edge repair","This cohort includes patients who underwent transcatheter edge-to-edge repair (TEER) for severe degenerative mitral regurgitation (DMR). The intervention involves a minimally invasive transcatheter procedure using a device to approximate the mitral valve leaflets, reducing regurgitation.",[74],{"name":75,"role":76,"phone":77,"phoneExt":62,"email":78},"Aakriti Gupta, M.D.","CONTACT","267-442-8776","aakriti.gupta@cshs.org",[80],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Smidt Heart Institute, Cedars Sinai Medical Center","RECRUITING","Los Angeles","California","90048","United States","US",{"type":89,"coordinates":90},"Point",[91,92],-118.24368,34.05223,{"lat":92,"lon":91},[95],{"name":75,"role":76,"phone":77,"phoneExt":62,"email":78},{"type":97,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":62,"oldOrganization":62},"PRINCIPAL_INVESTIGATOR","Aakriti Gupta","Assistant Professor, Cardiology",[101],{"name":102,"class":103},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100637625",false,"NCT07605715","Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation","Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation: A Comparative Study of Clinical Outcomes, Patient Experiences, and Mechanistic Insights With Multimodality Imaging","DMR","Inclusion Criteria:\n\n* Patients older than 60 years who have DMR will be included in the study\n\nExclusion Criteria:\n\n* Patients with prior history of mitral intervention or surgery will be excluded.\n* Patient records flagged \"break the glass\" or \"research opt out\" will be excluded.\n* Persons with allergy to animal dander or animal-instigated asthma will be excluded.","ALL","60 Years",{"count":114,"type":115},60,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term. The study aims to:\n\n1. Evaluate the effectiveness and safety of TEER versus surgery in patients with DMR over long term.\n2. Investigate the predictors of left ventricular dysfunction and clinical outcomes using advanced imaging techniques, such as cardiac MRI\n3. Assess patient-reported recovery and quality of life outcomes using validated tools.\n\nThe study focuses on improving care strategies for patients with DMR, particularly those at higher surgical risk, by identifying optimal treatment approaches and predictors of recovery.",[119],"Degenerative Mitral Valve Disease",[121,122,68],"TEER","Transcatheter mitral repair","2026-05-18",{"date":125,"type":126},"2026-05-26","ACTUAL",{"date":128,"type":126},"2025-02-19",{"date":130,"type":115},"2027-08",{"name":5,"class":6},1]