[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"XSpline S.p.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Cardiac Resynchronization Therapy","Chronic Heart Failure","Left Bundle-Branch Block",[31,32],"Non-invasive activation mapping","Coronary Sinus","RECRUITING","2024-10-22",{"date":36,"type":37},"2024-10-24","ACTUAL",{"date":39,"type":37},"2023-03-06",{"date":41,"type":21},"2025-09",{"name":43,"class":44},"XSpline S.p.A.","INDUSTRY",13,""]