[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05051033":3,"trial-entities:NCT05051033":619,"trial-summary:NCT05051033":623},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":45,"secondary_outcomes":50,"sex":138,"minimum_age":139,"maximum_age":140,"healthy_volunteers":141,"eligibility_criteria":142,"std_ages":172,"locations":175,"central_contacts":602,"overall_officials":603,"references":614,"see_also_links":615},"NCT05051033","STUDY-21-01246","Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)","ACTIVE_NOT_RECRUITING","2030-11-15","2026-06","2026-06-24","2022-02-21","Annetine Gelijns","OTHER",true,"This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.","The primary aim of this study is to evaluate the long-term effectiveness and safety of MV TEER compared with surgical repair in patients with primary, degenerative MR. The secondary aim is to analyze the relationship between the adequacy of MR correction at one-year post intervention and longer-term clinical outcomes (death, heart failure hospitalizations\u002Furgent care visits, valve re-interventions, and quality of life). The tertiary aim of this trial is to evaluate a range of patient-centered outcomes (quality of life, functional status, and discharge location) of transcatheter edge-to-edge MV repair compared with MV surgical repair in patients with primary, degenerative mitral regurgitation. This study is closely integrated with the PRIMARY Ancillary Substudy (NCT07103733)\n\nThe patient population for this trial consists of adult patients with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible.\n\nBecause the use of the commercial edge-to-edge mitral repair device in the U.S. is approved only in patients considered to be at prohibitive risk of MV surgery by a heart team, use of such devices in this trial is considered investigational by the FDA. As such, this trial will be conducted under an Investigational Device Exemption (IDE).\n\nOutcomes will be measured from randomization over a period of 5 years post intervention. The estimated enrollment period is 36 months, and all patients will be followed from randomization for up to 10 years post intervention for particular endpoints. Long-term follow-up will include leveraging administrative datasets linked to clinical trial data.",[18],"Mitral Valve Regurgitation",[20,21],"surgical mitral valve repair","transcatheter edge-to-edge repair","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},450,"ACTUAL",[30,38],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"PROCEDURE","Mitral valve repair","Patients who are randomized to the surgical arm will undergo mitral surgery. Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance. Standard techniques commonly include a ring or band annuloplasty to correct and prevent annular dilatation; leaflet prolapse and redundancy may be corrected by leaflet resection techniques and \u002F or chordal reconstruction.",[35],"Surgical mitral valve repair",[37],"Mitral valve surgery",{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DEVICE","Transcatheter edge-to-edge repair","Patients will be treated with a commercially-approved edge-to-edge mitral repair device. The steerable guide catheter (guide) is inserted into the femoral vein and advanced across the inter-atrial septum using image guided puncture. Fluoroscopic and echocardiographic guidance will be used to visualize the devices and assess the repair. The guide is positioned over the MV and the clip\u002Fclasp delivery system is inserted into the guide and positioned over the MV in accordance with the manufacturer's instructions. The delivery catheter is advanced until the clip\u002Fclasp emerges from the tip of the guide into the left atrium. The catheter is manipulated using the control handle until the clip\u002Fclasp is correctly oriented with respect to the line of coaptation of the mitral valve. The clip\u002Fclasp is opened, and advanced across the mitral valve into the left ventricle then pulled back to grasp the leaflets.",[40],[44],"TEER",[46],{"measure":47,"description":48,"timeFrame":49},"All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) composite score.","All-cause mortality, valve re-intervention, hospitalizations\u002Furgent visits for heart failure (without a blanking period), or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) from randomization to a minimum of 3 years post intervention.\n\nComposite score will be expressed as a Z-score - The Z-Score is a statistical measurement of a score's relationship to the mean in a group of scores. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher than the mean.","3 years post intervention",[51,55,59,63,65,69,72,76,78,81,83,86,90,93,96,99,102,105,108,111,115,119,122,125,128,131,134],{"measure":52,"description":53,"timeFrame":54},"Adequacy of MR correction","Adequacy of MR correction at one year post intervention, defined as \\\u003C 2+ MR as assessed by TTE","one year post intervention",{"measure":56,"description":57,"timeFrame":58},"Kansas City Cardiomyopathy Questionnaire (KCCQ)","Disease-specific quality of life as measured by the KCCQ at 6-month time intervals up to 5 years. KCCQ has 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy. The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score. All scores are scaled 0 to 100, with higher scores indicating better health outcome.","up to 10 years post intervention",{"measure":60,"description":61,"timeFrame":62},"Procedure failure","Procedure failure defined as residual moderately severe or severe (3+ or 4+\u002F4+) MR at the end of the procedure, or conversion of a TEER to an open surgical repair or replacement, or conversion of a surgical mitral valve repair to a mitral valve replacement procedure.","End of procedure",{"measure":60,"description":61,"timeFrame":64},"10 years post randomization",{"measure":66,"description":67,"timeFrame":68},"All-cause mortality","All-cause mortality through 5 years post randomization","5 years post randomization",{"measure":66,"description":70,"timeFrame":71},"All-cause mortality from randomization through 10 years post intervention","10 years post intervention",{"measure":73,"description":74,"timeFrame":75},"Cardiovascular and non-cardiovascular mortality","Cardiovascular and non-cardiovascular mortality from randomization through 5 years post intervention","5 years post intervention",{"measure":73,"description":77,"timeFrame":71},"Cardiovascular and non-cardiovascular mortality from randomization through 10 years post intervention",{"measure":79,"description":80,"timeFrame":75},"Valve re-interventions","Valve re-interventions through 5 years post intervention",{"measure":79,"description":82,"timeFrame":71},"Valve re-interventions through 10 years post intervention",{"measure":84,"description":85,"timeFrame":75},"Serious or protocol-defined adverse events","Serious or protocol-defined adverse events, including stroke, acute kidney injury (AKI), and renal failure, through 5 years",{"measure":87,"description":88,"timeFrame":89},"MR grade","Mitral Regurgitation (MR) grade as mild, moderate, or severe. (grade I-IV, with higher grade indicating poorer health outcomes.)","up to 6 years post intervention",{"measure":91,"description":92,"timeFrame":89},"Left Ventricular Ejection Fraction (LVEF)","Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction.",{"measure":94,"description":95,"timeFrame":89},"Left Ventricular End Diastolic Dimension (LVEDD)","Left ventricular end diastolic dimension (LVEDD) is the diameter across the left ventricle of the heart at the end of diastole, that is, when the heart muscle is maximally relaxed, and usually corresponds to its largest diameter.",{"measure":97,"description":98,"timeFrame":89},"Left Ventricular End Systolic Dimension (LVESD)","Left ventricular end systolic dimension (LVESD) is the diameter across the left ventricle of the heart at the end of systole, that is, when the heart muscle is maximally contracted, and usually corresponds to its smallest diameter.",{"measure":100,"description":101,"timeFrame":89},"Left Ventricular End Diastolic Volume (LVEDV)","Left Ventricular end diastolic volume (LVEDV) is the volume of blood in the left ventricle at the end of the diastole or ventricular filling.",{"measure":103,"description":104,"timeFrame":89},"Left Ventricular End Systolic Volume (LVESV)","Left Ventricular end systolic volume (LVESV) is the volume of blood in the left ventricle at the end of the systolic ejection phase immediately before the beginning of diastole or ventricular filling.",{"measure":106,"description":107,"timeFrame":89},"Mitral valve gradient","The valve gradient is the difference in pressure on each side of the valve. When a valve is narrowed (a condition called stenosis), the pressure on the front of the valve builds up as blood is forced through the narrow opening. This causes a larger pressure difference between the front and back of the valve. The valve gradient can be used to determine the severity of the valve disorder.",{"measure":109,"description":110,"timeFrame":89},"Forward stroke volume","The forward stroke volume is the volume entering the aorta.",{"measure":112,"description":113,"timeFrame":114},"6 Minute Walk Test (6MWT)","Functional status as measured by the 6MWT at yearly time intervals over 5 years. 6MT - The distance covered over a time of 6 minutes","up to 5 years post intervention",{"measure":116,"description":117,"timeFrame":118},"EuroQol- 5 Dimension (EQ-5D)","Generic QoL as measured by the EuroQol-5D (EQ-5D). The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).","through 10 years post intervention",{"measure":120,"description":121,"timeFrame":118},"Length of stay (LOS)","Length of stay as measured by number of days hospitalized.",{"measure":123,"description":124,"timeFrame":118},"ICU days of index hospitalization","Number of ICU days of index hospitalization",{"measure":126,"description":127,"timeFrame":118},"Number and reasons for readmissions","Number and reasons for readmissions, including for valve re-intervention and readmissions\u002Furgent visits for heart failure",{"measure":129,"description":130,"timeFrame":118},"Cost","Costs associated with the index hospitalization as well as follow-up readmissions will be measured.",{"measure":132,"description":133,"timeFrame":118},"Cost-effectiveness","A cost-effectiveness analysis (CEA) comparing cumulative costs and quality-adjusted life years (QALYs) of transcatheter edge-to-edge repair vs surgical repair will be performed from U.S., Canadian, German and United Kingdom health care sector perspectives according to national guidelines.",{"measure":135,"description":136,"timeFrame":137},"Number of participants with stroke with disability","Stroke with disability is defined as a modified Rankin score of ≥ 2 and\u002For major bleeding (BARC Type 3b, 3c and 5) by 30 days post-intervention","30 days post-intervention","ALL","60 Years",null,false,{"inclusion":143,"exclusion":149,"raw_text":171},[144,145,146,147,148],"Adult patients ≥60 years with moderately-severe or severe (3+ or 4+\u002F4+) primary degenerative (Carpentier type II) MR defined by transthoracic echocardiography","Clinical indication for MV intervention and anatomic candidate for both surgical MV repair and transcatheter edge-to-edge repair (TEER) per local heart team assessment with central eligibility committee verification","Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on local heart team assessment and central eligibility committee verification (see ACC\u002FAHA 2020 guidelines for the management of patients with valvular heart disease)","Patients with AF who meet an indication for a concomitant ablation procedure be included provided the local heart team and central eligibility committee decide they are eligible for both catheter-based and surgical ablation.","Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument",[150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170],"Non-degenerative types of primary MR (e.g., cleft leaflet)","Secondary or functional MR","Hypertrophic obstructive cardiomyopathy","Presence of an IVC filter or permanent pacing\u002FICD leads that would interfere with TEER per local heart team assessment","Known allergic reactions to intravenous contrast","Febrile illness within 30-days prior to randomization","Any absolute contraindication to transesophageal echocardiography","Any contraindication to systemic heparinization including active bleeding diatheses, and heparin induced thrombocytopenia","Patients with CAD requiring revascularization","Any prior mitral valve intervention or any prior repair of atrial septal defect","Any prior MV intervention or any prior repair of atrial septal defect","Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery","Need for any emergency intervention or surgery","Active endocarditis","Hemodynamic instability defined as cardiac index \\\u003C2.0 l\u002Fmin\u002Fm2 or systolic blood pressure \\\u003C90mmHg or need for inotropic support or any mechanical circulatory support","Left ventricular ejection fraction \\\u003C25%","Intracardiac mass or thrombus","Co-morbid medical or oncologic condition for which local heart team believes that survival beyond 2 years is unlikely","Active substance abuse","Suspected inability to adhere to follow-up","Treatment with another investigational drug or other intervention, assessment of which has not completed the primary endpoint or that clinically interferes with the present study endpoints.","The patient population for this trial consists of adults with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible. Specific inclusion and exclusion criteria are listed below. All patients who meet eligibility criteria will be included in the study regardless of gender, race, or ethnicity.\n\nInclusion Criteria:\n\n* Adult patients ≥60 years with moderately-severe or severe (3+ or 4+\u002F4+) primary degenerative (Carpentier type II) MR defined by transthoracic echocardiography\n* Clinical indication for MV intervention and anatomic candidate for both surgical MV repair and transcatheter edge-to-edge repair (TEER) per local heart team assessment with central eligibility committee verification\n* Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on local heart team assessment and central eligibility committee verification (see ACC\u002FAHA 2020 guidelines for the management of patients with valvular heart disease)\n* Patients with AF who meet an indication for a concomitant ablation procedure be included provided the local heart team and central eligibility committee decide they are eligible for both catheter-based and surgical ablation.\n* Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument\n\nExclusion Criteria:\n\n* Non-degenerative types of primary MR (e.g., cleft leaflet)\n* Secondary or functional MR\n* Hypertrophic obstructive cardiomyopathy\n* Presence of an IVC filter or permanent pacing\u002FICD leads that would interfere with TEER per local heart team assessment\n* Known allergic reactions to intravenous contrast\n* Febrile illness within 30-days prior to randomization\n* Any absolute contraindication to transesophageal echocardiography\n* Any contraindication to systemic heparinization including active bleeding diatheses, and heparin induced thrombocytopenia\n* Patients with CAD requiring revascularization\n* Any prior mitral valve intervention or any prior repair of atrial septal defect\n* Any prior MV intervention or any prior repair of atrial septal defect\n* Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery\n* Need for any emergency intervention or surgery\n* Active endocarditis\n* Hemodynamic instability defined as cardiac index \\\u003C2.0 l\u002Fmin\u002Fm2 or systolic blood pressure \\\u003C90mmHg or need for inotropic support or any mechanical circulatory support\n* Left ventricular ejection fraction \\\u003C25%\n* Intracardiac mass or thrombus\n* Co-morbid medical or oncologic condition for which local heart team believes that survival beyond 2 years is unlikely\n* Active substance abuse\n* Suspected inability to adhere to follow-up\n* Treatment with another investigational drug or other intervention, assessment of which has not completed the primary endpoint or that clinically interferes with the present study endpoints.",[173,174],"ADULT","OLDER_ADULT",[176,185,189,196,203,211,215,223,231,239,247,251,259,267,275,282,286,289,297,305,313,321,329,337,345,354,362,369,376,384,393,401,404,411,418,425,432,439,446,450,457,464,471,478,485,492,501,508,515,522,531,538,544,548,552,559,567,574,581,588,592,599],{"facility":177,"city":178,"state":179,"zip":180,"country":181,"geoPoint":182},"Keck Hospital of the University of Southern California","Los Angeles","California","90033","United States",{"lat":183,"lon":184},34.05223,-118.24368,{"facility":186,"city":178,"state":179,"zip":187,"country":181,"geoPoint":188},"Cedars Sinai Medical Center","90048",{"lat":183,"lon":184},{"facility":190,"city":191,"state":179,"zip":192,"country":181,"geoPoint":193},"University of California San Francisco","San Francisco","94143",{"lat":194,"lon":195},37.77493,-122.41942,{"facility":197,"city":198,"state":179,"zip":199,"country":181,"geoPoint":200},"Stanford University","Stanford","94305",{"lat":201,"lon":202},37.42411,-122.16608,{"facility":204,"city":205,"state":206,"zip":207,"country":181,"geoPoint":208},"Piedmont Heart Institute","Atlanta","Georgia","30309",{"lat":209,"lon":210},33.749,-84.38798,{"facility":212,"city":205,"state":206,"zip":213,"country":181,"geoPoint":214},"Emory University","30322",{"lat":209,"lon":210},{"facility":216,"city":217,"state":218,"zip":219,"country":181,"geoPoint":220},"Ochsner Clinic","New Orleans","Louisiana","70121",{"lat":221,"lon":222},29.95465,-90.07507,{"facility":224,"city":225,"state":226,"zip":227,"country":181,"geoPoint":228},"Maine Medical Center","Portland","Maine","04102",{"lat":229,"lon":230},43.65737,-70.2589,{"facility":232,"city":233,"state":234,"zip":235,"country":181,"geoPoint":236},"The Johns Hopkins Hospital","Baltimore","Maryland","21287",{"lat":237,"lon":238},39.29038,-76.61219,{"facility":240,"city":241,"state":242,"zip":243,"country":181,"geoPoint":244},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":245,"lon":246},42.35843,-71.05977,{"facility":248,"city":241,"state":242,"zip":249,"country":181,"geoPoint":250},"Brigham and Women's","02115",{"lat":245,"lon":246},{"facility":252,"city":253,"state":254,"zip":255,"country":181,"geoPoint":256},"University of Michigan Hospital","Ann Arbor","Michigan","48109",{"lat":257,"lon":258},42.27756,-83.74088,{"facility":260,"city":261,"state":262,"zip":263,"country":181,"geoPoint":264},"Saint Luke's Hospital of Kansas City\u002FMidAmerica Heart and Lung Surgeons","Kansas City","Missouri","64111",{"lat":265,"lon":266},39.09973,-94.57857,{"facility":268,"city":269,"state":270,"zip":271,"country":181,"geoPoint":272},"Dartmouth Hitchcock Medical Center","Lebanon","New Hampshire","03756",{"lat":273,"lon":274},43.64229,-72.25176,{"facility":276,"city":277,"state":277,"zip":278,"country":181,"geoPoint":279},"New York-Presbyterian\u002FColumbia University Medical Center","New York","10032",{"lat":280,"lon":281},40.71427,-74.00597,{"facility":283,"city":277,"state":277,"zip":284,"country":181,"geoPoint":285},"Weill Cornell Medicine\u002F New York-Presbyterian Hospital","10065",{"lat":280,"lon":281},{"facility":287,"city":277,"state":277,"zip":235,"country":181,"geoPoint":288},"Northwell Health",{"lat":280,"lon":281},{"facility":290,"city":291,"state":292,"zip":293,"country":181,"geoPoint":294},"Duke University Hospital","Durham","North Carolina","27710",{"lat":295,"lon":296},35.99403,-78.89862,{"facility":298,"city":299,"state":300,"zip":301,"country":181,"geoPoint":302},"Cleveland Clinic","Cleveland","Ohio","44195",{"lat":303,"lon":304},41.4995,-81.69541,{"facility":306,"city":307,"state":308,"zip":309,"country":181,"geoPoint":310},"Hospital of the University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"lat":311,"lon":312},39.95238,-75.16362,{"facility":314,"city":315,"state":316,"zip":317,"country":181,"geoPoint":318},"Medical University of South Carolina","Charleston","South Carolina","29425",{"lat":319,"lon":320},32.77632,-79.93275,{"facility":322,"city":323,"state":324,"zip":325,"country":181,"geoPoint":326},"Baylor, Scott and White","Dallas","Texas","75246",{"lat":327,"lon":328},32.78306,-96.80667,{"facility":330,"city":331,"state":332,"zip":333,"country":181,"geoPoint":334},"University of Virginia Medical Center","Charlottesville","Virginia","22903",{"lat":335,"lon":336},38.02931,-78.47668,{"facility":338,"city":339,"state":340,"zip":341,"country":181,"geoPoint":342},"West Virginia University Hospital","Morgantown","West Virginia","26506",{"lat":343,"lon":344},39.62953,-79.9559,{"facility":346,"city":347,"state":348,"zip":349,"country":350,"geoPoint":351},"University of British Columbia, Providence Health Care, St. Paul's Hospital","Vancouver","British Columbia","BC V6E 1M7","Canada",{"lat":352,"lon":353},49.24966,-123.11934,{"facility":355,"city":356,"state":357,"zip":358,"country":350,"geoPoint":359},"London Health Sciences","London","Ontario","ON N6A 5W9",{"lat":360,"lon":361},42.98339,-81.23304,{"facility":363,"city":364,"state":357,"zip":365,"country":350,"geoPoint":366},"University of Ottawa Heart Institute","Ottawa","K1Y 4W7",{"lat":367,"lon":368},45.41117,-75.69812,{"facility":370,"city":371,"state":357,"zip":372,"country":350,"geoPoint":373},"Unity Health Toronto (St. Michael's Hospital)","Toronto","M5B 1W8St",{"lat":374,"lon":375},43.70643,-79.39864,{"facility":377,"city":378,"state":379,"zip":380,"country":350,"geoPoint":381},"Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University)","Québec","Quebec","QC G1V 4G5",{"lat":382,"lon":383},46.81228,-71.21454,{"facility":385,"city":386,"state":387,"zip":388,"country":389,"geoPoint":390},"Universitätsklinikum Köln","Cologne","Berlin-kölnische Allee","50969","Germany",{"lat":391,"lon":392},50.93333,6.95,{"facility":394,"city":395,"state":396,"zip":397,"country":389,"geoPoint":398},"Herz- und Diabeteszentrum NRW","Bad Oeynhausen","North Rhine-Westphalia","32545",{"lat":399,"lon":400},52.20699,8.80365,{"facility":385,"city":386,"state":396,"zip":402,"country":389,"geoPoint":403},"50937",{"lat":391,"lon":392},{"facility":405,"city":406,"zip":407,"country":389,"geoPoint":408},"Kerckhoff Klinik Bad Nauheim","Bad Nauheim","61231",{"lat":409,"lon":410},50.36463,8.73859,{"facility":412,"city":413,"zip":414,"country":389,"geoPoint":415},"Schüchtermann-Klinik Bad Rothenfelde","Bad Rothenfelde","49214",{"lat":416,"lon":417},52.11667,8.16667,{"facility":419,"city":420,"zip":421,"country":389,"geoPoint":422},"Deutsches Herzzentrum der Charité","Berlin","13353",{"lat":423,"lon":424},52.52437,13.41053,{"facility":426,"city":427,"zip":428,"country":389,"geoPoint":429},"Universitätsklinikum Frankfurt","Frankfurt","60590",{"lat":430,"lon":431},49.68333,10.53333,{"facility":433,"city":434,"zip":435,"country":389,"geoPoint":436},"Universitätsklinikum Freiburg","Freiburg im Breisgau","79106",{"lat":437,"lon":438},47.9959,7.85222,{"facility":440,"city":441,"zip":442,"country":389,"geoPoint":443},"Asklepios Klinik St. Georg Hamburg","Hamburg","20099",{"lat":444,"lon":445},53.55073,9.99302,{"facility":447,"city":441,"zip":448,"country":389,"geoPoint":449},"Universitätsklinikum Hamburg Eppendorf","20246",{"lat":444,"lon":445},{"facility":451,"city":452,"zip":453,"country":389,"geoPoint":454},"Universitätsklinikum Heidelberg","Heidelberg","69120",{"lat":455,"lon":456},49.40768,8.69079,{"facility":458,"city":459,"zip":460,"country":389,"geoPoint":461},"Universitätsklinikum Jena","Jena","07747",{"lat":462,"lon":463},50.92878,11.5899,{"facility":465,"city":466,"zip":467,"country":389,"geoPoint":468},"Universitätsklinikum Schleswig-Holstein Campus Kiel","Kiel","24105",{"lat":469,"lon":470},54.32133,10.13489,{"facility":472,"city":473,"zip":474,"country":389,"geoPoint":475},"Herzzentrum Leipzig","Leipzig","04289",{"lat":476,"lon":477},51.33962,12.37129,{"facility":479,"city":480,"zip":481,"country":389,"geoPoint":482},"Universitätsklinikum Schleswig-Holstein Campus Lübeck","Lübeck","23538",{"lat":483,"lon":484},53.86893,10.68729,{"facility":486,"city":487,"zip":488,"country":389,"geoPoint":489},"Deutsches Herzzentrum München","München","80636",{"lat":490,"lon":491},51.60698,13.31243,{"facility":493,"city":494,"state":495,"zip":496,"country":497,"geoPoint":498},"Hospital Alvaro Cunqueiro","Vigo","Galacia","36204","Spain",{"lat":499,"lon":500},42.23282,-8.72264,{"facility":502,"city":503,"zip":504,"country":497,"geoPoint":505},"Hospital Clinic De Barcelona","Barcelona","08036",{"lat":506,"lon":507},41.38879,2.15899,{"facility":509,"city":510,"zip":511,"country":497,"geoPoint":512},"Hospital Clínico San Carlos","Madrid","28040",{"lat":513,"lon":514},40.4165,-3.70256,{"facility":516,"city":517,"zip":518,"country":497,"geoPoint":519},"Hospital Central de Asturias","Oviedo","33011",{"lat":520,"lon":521},43.36029,-5.84476,{"facility":523,"city":524,"state":525,"zip":526,"country":527,"geoPoint":528},"Royal Papworth Hospital NHS Foundation Trust","Cambridge","England","CB2 0AY","United Kingdom",{"lat":529,"lon":530},52.2,0.11667,{"facility":532,"city":533,"state":525,"zip":534,"country":527,"geoPoint":535},"The Leeds Teaching Hospitals NHS Trust","Leeds","LS1 3EX",{"lat":536,"lon":537},53.79648,-1.54785,{"facility":539,"city":356,"state":525,"zip":540,"country":527,"geoPoint":541},"St. Thomas Guy's and St Thomas' NHS Foundation Trust","SE1 7EH",{"lat":542,"lon":543},51.50853,-0.12574,{"facility":545,"city":356,"state":525,"zip":546,"country":527,"geoPoint":547},"King's College Hospital NHS Foundation Trust","SE5 9RS",{"lat":542,"lon":543},{"facility":549,"city":356,"state":525,"zip":550,"country":527,"geoPoint":551},"Royal Brompton and Harefield Guy's and St Thomas' NHS Foundation Trust","SW3 6NP",{"lat":542,"lon":543},{"facility":553,"city":554,"state":525,"zip":555,"country":527,"geoPoint":556},"Manchester University NHS Foundation Trust","Manchester","M23 9LT",{"lat":557,"lon":558},53.48095,-2.23743,{"facility":560,"city":561,"state":562,"zip":563,"country":527,"geoPoint":564},"University Hospitals Sussex NHS Foundation Trust","Worthing","West Sussex","BN2 5BE",{"lat":565,"lon":566},50.81795,-0.37538,{"facility":568,"city":569,"zip":570,"country":527,"geoPoint":571},"University Hospitals Birmingham NHS Foundation Trust","Birmingham","B15 2TH",{"lat":572,"lon":573},52.48142,-1.89983,{"facility":575,"city":576,"zip":577,"country":527,"geoPoint":578},"Golden Jubilee University National Hospital","Clydebank","G81 4DY",{"lat":579,"lon":580},55.90137,-4.4057,{"facility":582,"city":583,"zip":584,"country":527,"geoPoint":585},"Oxford University Hospitals NHS Foundation Trust","Headington","OX3 9DU",{"lat":586,"lon":587},51.75737,-1.21974,{"facility":589,"city":356,"zip":590,"country":527,"geoPoint":591},"Barts Health NHS Trust","E1 8PR",{"lat":542,"lon":543},{"facility":593,"city":594,"zip":595,"country":527,"geoPoint":596},"South Tees Hospitals NHS Foundation Trust","Middlesbrough","TS4 3BW",{"lat":597,"lon":598},54.57623,-1.23483,{"facility":600,"city":594,"country":527,"geoPoint":601},"South Tees Hospital NHS Foundation Trust",{"lat":597,"lon":598},[],[604,608,611],{"name":605,"affiliation":606,"role":607},"Joanna Chikwe, MD","Cedars Sinai","STUDY_DIRECTOR",{"name":609,"affiliation":610,"role":607},"Martin Leon, MD","Columbia University",{"name":612,"affiliation":613,"role":607},"Patrick O'Gara, MD","Brigham and Women's Hospital",[],[616],{"label":617,"url":618},"PRIMARY Ancillary Substudy","https:\u002F\u002Fclinicaltrials.gov\u002Fstudy\u002FNCT07103733",{"nct_id":4,"conditions":620,"biomarkers":622},[621],"Mitral Valve Insufficiency",[],{"nct_id":4,"found":14,"summary":624,"prompt_version":632},{"design":625,"status":626,"heading":6,"summary":627,"follow_up":625,"word_count":628,"commitments":629,"compensation":630,"drugs_mentioned":631},"Not specified.","completed","{\n   \"Percutaneous or Surgical Repair for Mitral Prolapse and Regurgitation\",\n   \"This study is comparing two ways to fix severe mitral regurgitation (a leaky heart valve) in people aged 60 and older. You would receive either a transcatheter edge-to-edge repair (TEER), where a device is inserted through a vein to help the valve close better, or traditional surgery to repair the valve. The study wants to see which method is safer and more effective over the long term. To join, your heart team must agree that both repair options are suitable for you. The study is looking at how well the valve is repaired, hospital stays, and overall health after 3 years. We don't know the current recruitment status.\",\n  \"design\": \"This is a randomized study comparing two treatments, with about 450 participants planned. It is an open-label study, meaning both you and your doctors will know which treatment you receive.\",\n  \"commitments\": \"You would undergo either a transcatheter edge-to-edge repair or mitral valve surgery. The study will then track your health and valve function for 3 years.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be followed for 3 years after their intervention to assess long-term outcomes.\",\n}",198,"Not specified in the trial record.","Not stated in the trial record.",[40],"v2"]