[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519102":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":38,"centralContacts":42,"locations":51,"responsibleParty":136,"collaborators":138,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":10,"eligibilityCriteria":156,"healthyVolunteers":153,"sex":157,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":10,"studyType":163,"phases":10,"briefSummary":164,"conditions":165,"keywords":10,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"International Consortium of Circulatory Assist Clinicians","OTHER",[8,14,17,20,23,26,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Mayo Clinic",null,"Obtain demographic and clinical data prior to and following implantation of a HeartMate 3 ® device. HeartMate 3® downloaded pump operations data will be obtained at the following scheduled intervals: discharge from the ICU, at the time of discharge from the hospital (or ± 3 days from discharge), 3-months post-implant, 6-months post-implant, and lastly at 12-months post-implant. Downloadable pump operations data will include evaluation of suction events, low flow and other adventitious alarms, PI events and incidence of power cable disconnects beyond 20 seconds. The previously mentioned data will also be collected during any unplanned office visits, any admission regardless of the reason, unplanned ER visits related to equipment problems or any serious adverse event-related ER visits.",[13],"Device: HeartMate 3 (R) left ventricular assist device",{"label":15,"type":10,"description":11,"interventionNames":16},"University of Florida",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"University of Utah",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"University of California, San Francisco",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"University of Chicago",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"University of Kansas Medical System",[13],{"label":30,"type":10,"description":11,"interventionNames":31},"Medical University of South Carolina",[13],[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"DEVICE","HeartMate 3 (R) left ventricular assist device","No direct intervention; this is prospective study analysis of pump data from the HeartMate 3 (R) left ventricular assist device with clinical correlation to a multitude of variables and conditions we see clinically",[9,30,21,24,15,27,18],[39],{"name":40,"affiliation":5,"role":41},"Sarah E Schroeder, PhD MSN RN","PRINCIPAL_INVESTIGATOR",[43,47],{"name":40,"role":44,"phone":45,"phoneExt":10,"email":46},"CONTACT","402-937-3595","sarah.schroeder@vadcoordinator.org",{"name":48,"role":44,"phone":49,"phoneExt":10,"email":50},"Thomas Schloglhofer, MSc","+43 650 7119129","thomas.schloeglhofer@meduniwien.ac.at",[52,69,81,93,104,117,127],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"UCSF","RECRUITING","San Francisco","California","94143","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-122.41942,37.77493,{"lat":64,"lon":63},[67],{"name":68,"role":44,"phone":10,"phoneExt":10,"email":10},"Sylvie Baudart",{"facility":15,"status":54,"city":70,"state":71,"zip":72,"country":58,"countryCode":59,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Gainesville","Florida","32611",{"type":61,"coordinates":74},[75,76],-82.32483,29.65163,{"lat":76,"lon":75},[79],{"name":80,"role":44,"phone":10,"phoneExt":10,"email":10},"Sara Geiger",{"facility":24,"status":54,"city":82,"state":83,"zip":84,"country":58,"countryCode":59,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Chicago","Illinois","60637",{"type":61,"coordinates":86},[87,88],-87.65005,41.85003,{"lat":88,"lon":87},[91],{"name":92,"role":44,"phone":10,"phoneExt":10,"email":10},"Krystina Chickerillo",{"facility":94,"status":95,"city":96,"state":97,"zip":98,"country":58,"countryCode":59,"cosmosGeoPoint":99,"geoPoint":103,"contacts":10},"University of Kansas Medical Center","ACTIVE_NOT_RECRUITING","Kansas City","Kansas","66103",{"type":61,"coordinates":100},[101,102],-94.62746,39.11417,{"lat":102,"lon":101},{"facility":105,"status":54,"city":106,"state":107,"zip":108,"country":58,"countryCode":59,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Mayo Clinic-Rochester","Rochester","Minnesota","55902",{"type":61,"coordinates":110},[111,112],-92.4699,44.02163,{"lat":112,"lon":111},[115],{"name":116,"role":44,"phone":10,"phoneExt":10,"email":10},"Sarah Schettle, PA",{"facility":118,"status":95,"city":119,"state":120,"zip":121,"country":58,"countryCode":59,"cosmosGeoPoint":122,"geoPoint":126,"contacts":10},"MUSC","Charleston","South Carolina","29425",{"type":61,"coordinates":123},[124,125],-79.93275,32.77632,{"lat":125,"lon":124},{"facility":18,"status":95,"city":128,"state":129,"zip":130,"country":58,"countryCode":59,"cosmosGeoPoint":131,"geoPoint":135,"contacts":10},"Salt Lake City","Utah","84112",{"type":61,"coordinates":132},[133,134],-111.89105,40.76078,{"lat":134,"lon":133},{"type":137,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[139,142,144,145,146,147,148,149,150],{"name":140,"class":141},"Abbott","INDUSTRY",{"name":143,"class":6},"Medical University of Vienna",{"name":9,"class":6},{"name":15,"class":6},{"name":18,"class":6},{"name":94,"class":6},{"name":30,"class":6},{"name":24,"class":6},{"name":21,"class":6},"100519102","humanmachine-interface-what-the-heartmate-3--device-tells-us-about-the-future-100519102",false,"NCT06039176","Human\u002FMachine Interface: What the HeartMate 3 ® Device Tells Us About the Future","Inclusion Criteria:\n\n* 18 years of age or older\n* Scheduled Heartmate 3 ® dLVAD implantation\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* Scheduled for dLVAD that is NOT a Heartmate 3 (R) device","ALL","18 Years","100 Years",{"count":161,"type":162},150,"ESTIMATED","OBSERVATIONAL","Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac transplantation. Despite the decreasing size of the newest generation devices leading to a lessened occurrence of adverse events, bleeding and infection still remain a concern for clinicians, as well as a general lack of predictability towards adverse events in individuals with a dLVAD in place. There is a lack of description in the literature currently, regarding the interface between what the pump data provides and what is seen in clinical practice. There also is little known about the effects of what is provided in the pump data, in correlation to quality-of-life following dLVAD implantation.\n\nTherefore, the purpose of this study is to prospectively analyze normal and abnormal pump data through pump operations such as suction events, low flow alarms as well as other adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty and other various medical conditions and adverse events as defined by the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical practice application (quality of life, frailty and various medical conditions, and adverse events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate correlations and relationships of longitudinal normal and abnormal dLVAD pump operations data, to demographic and clinical variables. This study is the first study to evaluate HeartMate 3 ® dLVAD pump operations data over time for effectiveness in the clinical practice.",[166,167,168,169,170,171,172,173],"LVAD","Frailty","GI Bleed","Right Heart Failure","Infections","Hypertension","Arrhythmias","Stroke","2025-12-08",{"date":176,"type":177},"2025-12-16","ACTUAL",{"date":179,"type":177},"2023-10-27",{"date":181,"type":162},"2026-12-30",{"name":5,"class":6},7]