[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464389":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":221,"collaborators":20,"id":223,"slug":20,"hasResults":224,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":224,"sex":230,"minAge":231,"maxAge":20,"enrollmentInfo":232,"targetDuration":20,"studyType":235,"phases":236,"briefSummary":238,"conditions":239,"keywords":243,"overallStatus":65,"whyStopped":20,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},{"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",[33,52,63,80,96,111,126,139,151,165,177,192,207],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Rush University Medical center","NOT_YET_RECRUITING","Chicago","Illinois","60637","United States",{"type":41,"coordinates":42},"Point",[43,44],-87.65005,41.85003,{"lat":44,"lon":43},[47,50],{"name":48,"role":29,"phone":20,"phoneExt":20,"email":49},"Parikshit S Sharma","parikshit_S_Sharma@rush.edu",{"name":51,"role":29,"phone":20,"phoneExt":20,"email":20},"Parikshit S Sharma, MD",{"facility":53,"status":35,"city":36,"state":37,"zip":38,"country":39,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"The University of Chicago Medicine",{"type":41,"coordinates":55},[43,44],{"lat":44,"lon":43},[58,61],{"name":59,"role":29,"phone":20,"phoneExt":20,"email":60},"Gaurav Upadhyay","gupadhyay@medicine.bsd.uchicago.edu",{"name":62,"role":29,"phone":20,"phoneExt":20,"email":20},"Gaurav Upadhyay, MD",{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":39,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Massachusetts General Hospital","RECRUITING","Boston","Massachusetts","02114",{"type":41,"coordinates":70},[71,72],-71.05977,42.35843,{"lat":72,"lon":71},[75,78],{"name":76,"role":29,"phone":20,"phoneExt":20,"email":77},"Jag Singh","JSINGH@mgh.harvard.edu",{"name":79,"role":29,"phone":20,"phoneExt":20,"email":20},"William J Hucker, MD, PhD",{"facility":81,"status":65,"city":82,"state":83,"zip":84,"country":39,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Duke University Hospital","Durham","North Carolina","27710",{"type":41,"coordinates":86},[87,88],-78.89862,35.99403,{"lat":88,"lon":87},[91,94],{"name":92,"role":29,"phone":20,"phoneExt":20,"email":93},"Daniel Friedman","daniel.friedman@duke.edu",{"name":95,"role":29,"phone":20,"phoneExt":20,"email":20},"Daniel Friedman, MD",{"facility":97,"status":65,"city":98,"state":20,"zip":20,"country":99,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Ordensklinikum Linz Elisabethinen Hospital","Linz","Austria",{"type":41,"coordinates":101},[102,103],14.28611,48.30639,{"lat":103,"lon":102},[106,109],{"name":107,"role":29,"phone":20,"phoneExt":20,"email":108},"Helmut Puererfellner","helmut.puererfellner@ordensklinikum.at",{"name":110,"role":29,"phone":20,"phoneExt":20,"email":20},"Georgios Kollias, MSc",{"facility":112,"status":35,"city":113,"state":20,"zip":20,"country":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Semmelweis University","Budapest","Hungary",{"type":41,"coordinates":116},[117,118],19.04045,47.49835,{"lat":118,"lon":117},[121,124],{"name":122,"role":29,"phone":20,"phoneExt":20,"email":123},"Bela Merkely","merkely.bela@gmail.com",{"name":125,"role":29,"phone":20,"phoneExt":20,"email":20},"Bela Merkely, PhD DSc FESC",{"facility":127,"status":35,"city":128,"state":128,"zip":20,"country":129,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Fondazione IRCCS Policlinico San Matteo","Pavia","Italy",{"type":41,"coordinates":131},[132,133],9.15917,45.19205,{"lat":133,"lon":132},[136],{"name":137,"role":29,"phone":20,"phoneExt":20,"email":138},"Roberto Rordorf, MD","R.Rordorf@smatteo.pv.it",{"facility":140,"status":35,"city":141,"state":141,"zip":20,"country":129,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"University Tor Vergata","Roma",{"type":41,"coordinates":143},[144,145],11.10642,44.99364,{"lat":145,"lon":144},[148],{"name":149,"role":29,"phone":20,"phoneExt":20,"email":150},"Claudia Tamburro, MD","claudia.tamburro96@gmail.com",{"facility":152,"status":35,"city":153,"state":20,"zip":20,"country":129,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"General Hospital of Bolzano","Bolzano",{"type":41,"coordinates":155},[156,157],11.33982,46.49067,{"lat":157,"lon":156},[160,163],{"name":161,"role":29,"phone":20,"phoneExt":20,"email":162},"Rainer Oberhollenzer","rainer.oberhollenzer@sabes.it",{"name":164,"role":29,"phone":20,"phoneExt":20,"email":20},"Rainer Oberhollenzer, MD",{"facility":166,"status":35,"city":167,"state":20,"zip":20,"country":129,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Ospedale S. Maria del Carmine di Rovereto","Rovereto",{"type":41,"coordinates":169},[170,171],11.04053,45.8904,{"lat":171,"lon":170},[174],{"name":175,"role":29,"phone":20,"phoneExt":20,"email":176},"Maurizio del Greco, MD","maurizio.delgreco@apss.tn.it",{"facility":178,"status":35,"city":179,"state":20,"zip":20,"country":180,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Maastricht University Medical Center","Maastricht","Netherlands",{"type":41,"coordinates":182},[183,184],5.68889,50.84833,{"lat":184,"lon":183},[187,190],{"name":188,"role":29,"phone":20,"phoneExt":20,"email":189},"Kevin Vernooy","kevin.vernooy@mumc.nl",{"name":191,"role":29,"phone":20,"phoneExt":20,"email":20},"Kevin Vernooy, MD",{"facility":193,"status":65,"city":194,"state":20,"zip":20,"country":195,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Univeristat de Barcelona","Barcelona","Spain",{"type":41,"coordinates":197},[198,199],2.15899,41.38879,{"lat":199,"lon":198},[202,205],{"name":203,"role":29,"phone":20,"phoneExt":20,"email":204},"Lluis Mont","lmont@clinic.cat",{"name":206,"role":29,"phone":20,"phoneExt":20,"email":20},"Mont, MD",{"facility":24,"status":65,"city":208,"state":20,"zip":20,"country":209,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Lugano","Switzerland",{"type":41,"coordinates":211},[212,213],8.96004,46.01008,{"lat":213,"lon":212},[216,219],{"name":217,"role":29,"phone":20,"phoneExt":20,"email":218},"Angelo Auricchio","angelo.auricchio@eoc.ch",{"name":220,"role":29,"phone":20,"phoneExt":20,"email":20},"Tardu Özkartal, MD",{"type":222,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":233,"type":234},150,"ESTIMATED","INTERVENTIONAL",[237],"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.",[240,241,242],"Cardiac Resynchronization Therapy","Chronic Heart Failure","Left Bundle-Branch Block",[244,245],"Non-invasive activation mapping","Coronary Sinus","2024-10-22",{"date":248,"type":249},"2024-10-24","ACTUAL",{"date":251,"type":249},"2023-03-06",{"date":253,"type":234},"2025-09",{"name":5,"class":6},13]