[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464389":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":228,"collaborators":20,"id":230,"slug":231,"hasResults":232,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":232,"sex":238,"minAge":239,"maxAge":20,"enrollmentInfo":240,"targetDuration":20,"studyType":243,"phases":244,"briefSummary":246,"conditions":247,"keywords":251,"overallStatus":66,"whyStopped":20,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},{"fullName":5,"class":6},"XSpline S.p.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CRT implantation guided by XSpline","EXPERIMENTAL","The sample size estimation was based on two recent studies including CRT patients with similar clinical and demographic characteristics as in this study: the SMART-MSP and the SMART CRT. The SMART-MSP is a prospective, observational study that enrolled 584 CRT recipients at 52 US sites. In a typical modern CRT population, 75% of patients had a reduction of the end-systolic volume ≥ 15% at 6-month follow-up. The SMART-CRT study enrolled 699 CRT patients randomized to a treatment arm and a control group. At 6-months follow-up, a reduction of LVESV ≥15% was achieved for 67.7% of the patients in the control group and for 74.8% of those in the treatment arm. Therefore, it is assumed that in a modern CRT population at least 70% of the patients will have a reduction of the LVESV ≥15% of the baseline value at 6-months after CRT implantation. To demonstrate that this proportion of patients can be equally achieved with the approach tested in this study at least 150 patients need to be included.",[13],"Device: CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment","The following information and data will be obtained from the routine clinical work up of the patients: Patient demographics, cardiovascular medical history, and clinical examination; 12-lead ECG; Standard echocardiography; Computed tomography angiography for visualization of atria, ventricle, and coronary sinus.\n\nImaging data will be transferred to the cloud-based web-platform using a dedicated software provided by study sponsor. Data processing includes evaluating the quality of the data and calculation of various anatomical and electrical parameters, and identification of the target zone as a point in the target vein closest to the latest activation zone.\n\nLV-lead location is based on the information provided by the dedicated software followed by visual X-ray based verification of anatomically suitable\u002Fmost desirable position.\n\nThe patient will undergo CRT device implantation according to local protocols.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Angelo Auricchio, MD PhD FESC","Istituto Cardiocentro Ticino","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Claudia M Amatruda, PhD","CONTACT","+390471200372","amatruda@xspline.com",[33,53,64,81,97,113,129,143,155,169,181,197,213],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Rush University Medical center","NOT_YET_RECRUITING","Chicago","Illinois","60637","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-87.65005,41.85003,{"lat":45,"lon":44},[48,51],{"name":49,"role":29,"phone":20,"phoneExt":20,"email":50},"Parikshit S Sharma","parikshit_S_Sharma@rush.edu",{"name":52,"role":29,"phone":20,"phoneExt":20,"email":20},"Parikshit S Sharma, MD",{"facility":54,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},"The University of Chicago Medicine",{"type":42,"coordinates":56},[44,45],{"lat":45,"lon":44},[59,62],{"name":60,"role":29,"phone":20,"phoneExt":20,"email":61},"Gaurav Upadhyay","gupadhyay@medicine.bsd.uchicago.edu",{"name":63,"role":29,"phone":20,"phoneExt":20,"email":20},"Gaurav Upadhyay, MD",{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":39,"countryCode":40,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Massachusetts General Hospital","RECRUITING","Boston","Massachusetts","02114",{"type":42,"coordinates":71},[72,73],-71.05977,42.35843,{"lat":73,"lon":72},[76,79],{"name":77,"role":29,"phone":20,"phoneExt":20,"email":78},"Jag Singh","JSINGH@mgh.harvard.edu",{"name":80,"role":29,"phone":20,"phoneExt":20,"email":20},"William J Hucker, MD, PhD",{"facility":82,"status":66,"city":83,"state":84,"zip":85,"country":39,"countryCode":40,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Duke University Hospital","Durham","North Carolina","27710",{"type":42,"coordinates":87},[88,89],-78.89862,35.99403,{"lat":89,"lon":88},[92,95],{"name":93,"role":29,"phone":20,"phoneExt":20,"email":94},"Daniel Friedman","daniel.friedman@duke.edu",{"name":96,"role":29,"phone":20,"phoneExt":20,"email":20},"Daniel Friedman, MD",{"facility":98,"status":66,"city":99,"state":20,"zip":20,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Ordensklinikum Linz Elisabethinen Hospital","Linz","Austria","AT",{"type":42,"coordinates":103},[104,105],14.28611,48.30639,{"lat":105,"lon":104},[108,111],{"name":109,"role":29,"phone":20,"phoneExt":20,"email":110},"Helmut Puererfellner","helmut.puererfellner@ordensklinikum.at",{"name":112,"role":29,"phone":20,"phoneExt":20,"email":20},"Georgios Kollias, MSc",{"facility":114,"status":35,"city":115,"state":20,"zip":20,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Semmelweis University","Budapest","Hungary","HU",{"type":42,"coordinates":119},[120,121],19.04045,47.49835,{"lat":121,"lon":120},[124,127],{"name":125,"role":29,"phone":20,"phoneExt":20,"email":126},"Bela Merkely","merkely.bela@gmail.com",{"name":128,"role":29,"phone":20,"phoneExt":20,"email":20},"Bela Merkely, PhD DSc FESC",{"facility":130,"status":35,"city":131,"state":131,"zip":20,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Fondazione IRCCS Policlinico San Matteo","Pavia","Italy","IT",{"type":42,"coordinates":135},[136,137],9.15917,45.19205,{"lat":137,"lon":136},[140],{"name":141,"role":29,"phone":20,"phoneExt":20,"email":142},"Roberto Rordorf, MD","R.Rordorf@smatteo.pv.it",{"facility":144,"status":35,"city":145,"state":145,"zip":20,"country":132,"countryCode":133,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"University Tor Vergata","Roma",{"type":42,"coordinates":147},[148,149],11.10642,44.99364,{"lat":149,"lon":148},[152],{"name":153,"role":29,"phone":20,"phoneExt":20,"email":154},"Claudia Tamburro, MD","claudia.tamburro96@gmail.com",{"facility":156,"status":35,"city":157,"state":20,"zip":20,"country":132,"countryCode":133,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"General Hospital of Bolzano","Bolzano",{"type":42,"coordinates":159},[160,161],11.33982,46.49067,{"lat":161,"lon":160},[164,167],{"name":165,"role":29,"phone":20,"phoneExt":20,"email":166},"Rainer Oberhollenzer","rainer.oberhollenzer@sabes.it",{"name":168,"role":29,"phone":20,"phoneExt":20,"email":20},"Rainer Oberhollenzer, MD",{"facility":170,"status":35,"city":171,"state":20,"zip":20,"country":132,"countryCode":133,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Ospedale S. Maria del Carmine di Rovereto","Rovereto",{"type":42,"coordinates":173},[174,175],11.04053,45.8904,{"lat":175,"lon":174},[178],{"name":179,"role":29,"phone":20,"phoneExt":20,"email":180},"Maurizio del Greco, MD","maurizio.delgreco@apss.tn.it",{"facility":182,"status":35,"city":183,"state":20,"zip":20,"country":184,"countryCode":185,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Maastricht University Medical Center","Maastricht","Netherlands","NL",{"type":42,"coordinates":187},[188,189],5.68889,50.84833,{"lat":189,"lon":188},[192,195],{"name":193,"role":29,"phone":20,"phoneExt":20,"email":194},"Kevin Vernooy","kevin.vernooy@mumc.nl",{"name":196,"role":29,"phone":20,"phoneExt":20,"email":20},"Kevin Vernooy, MD",{"facility":198,"status":66,"city":199,"state":20,"zip":20,"country":200,"countryCode":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Univeristat de Barcelona","Barcelona","Spain","ES",{"type":42,"coordinates":203},[204,205],2.15899,41.38879,{"lat":205,"lon":204},[208,211],{"name":209,"role":29,"phone":20,"phoneExt":20,"email":210},"Lluis Mont","lmont@clinic.cat",{"name":212,"role":29,"phone":20,"phoneExt":20,"email":20},"Mont, MD",{"facility":24,"status":66,"city":214,"state":20,"zip":20,"country":215,"countryCode":216,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Lugano","Switzerland","CH",{"type":42,"coordinates":218},[219,220],8.96004,46.01008,{"lat":220,"lon":219},[223,226],{"name":224,"role":29,"phone":20,"phoneExt":20,"email":225},"Angelo Auricchio","angelo.auricchio@eoc.ch",{"name":227,"role":29,"phone":20,"phoneExt":20,"email":20},"Tardu Özkartal, MD",{"type":229,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100464389","cardiac-resynchronization-therapy-delivery-guided-non-invasive-electrical-and-venous-anatomy-assessment-100464389",false,"NCT05327062","Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment","CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment","CRT-DRIVE","Eligible subjects shall meet all following criteria:\n\n* Appropriately signed and dated informed consent.\n* Age ≥18 years at time of consent.\n* CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT (class I and IIA indication in patients with LBBB QRS morphology) or to 2017 AHA\u002FACC\u002FHFSA guidelines (COR I).\n* Sinus rhythm\n* QRS duration ≥130 ms\n* Left bundle branch block\n* Left ventricular ejection fraction ≤35%\n* Symptomatic heart failure NYHA class ≥ II\n* Documented stable medical treatment for at least 6 months\n* No cardiovascular intervention during the last 6 month\n\nExclusion Criteria are:\n\n* History of persistent or permanent atrial fibrillation\n* Previous pacemaker or ICD implantation\n* Indication to pacing due to bradycardia\n* Patients considered for His bundle pacing or cardiac conduction pacing\n* Patients with unstable angina\n* Subject experienced a recent myocardial infarction, within 40 days prior to enrollment\n* Subject underwent coronary artery bypass graft or valve surgery, within 90 days prior to enrollment\n* Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year\n* Subject is implanted with a left ventricular assist device\n* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure\n* Subject has severe aortic stenosis (with a valve area of \\\u003C1.0 cm2 or significant valve disease expected to be operated within study period)\n* Subject has congenital heart disease\n* Subject has a mechanical right-sided heart valve\n* Subject has a life expectancy of less than one year in the opinion of the investigator\n* Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control\n* Subject is enrolled in one or more concurrent studies that would confound the results of this study\n* Patients who have contraindications to CT scanning.\n* Patients with chronic kidney diseases and estimated glomerular filtration rate (eGMR) calculated based on CKD-EPI 2009 \\\u003C 40 ml\u002Fmin\u002F1.73m2","ALL","18 Years",{"count":241,"type":242},150,"ESTIMATED","INTERVENTIONAL",[245],"NA","The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from 3D activation sequence from ECG, and coronary venous anatomy from cardiac computed tomography. This CRT-roadmap will be used to guide LV lead placement to a coronary vein in an electrically late-activated region.\n\nStudy Hypothesis: At least 75% of patients undergoing a CRT implantation guided by non-invasive electrical and venous anatomy assessment (XSPLINE technology) will show a reduction of left ventricular end-systolic volume of 15% or more at 6-month evaluation.",[248,249,250],"Cardiac Resynchronization Therapy","Chronic Heart Failure","Left Bundle-Branch Block",[252,253],"Non-invasive activation mapping","Coronary Sinus","2024-10-22",{"date":256,"type":257},"2024-10-24","ACTUAL",{"date":259,"type":257},"2023-03-06",{"date":261,"type":242},"2025-09",{"name":5,"class":6},13]