Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Trial Parameters
Brief Summary
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. Study 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.
Eligibility Criteria
Eligible subjects shall meet all following criteria: * Appropriately signed and dated informed consent. * Age ≥18 years at time of consent. * 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/ACC/HFSA guidelines (COR I). * Sinus rhythm * QRS duration ≥130 ms * Left bundle branch block * Left ventricular ejection fraction ≤35% * Symptomatic heart failure NYHA class ≥ II * Documented stable medical treatment for at least 6 months * No cardiovascular intervention during the last 6 month Exclusion Criteria are: * History of persistent or permanent atrial fibrillation * Previous pacemaker or ICD implantation * Indication to pacing due to bradycardia * Patients considered for His bundle pacing or cardiac conduction pacing * Patients with unstable angina * Subject experienced a recent myocardial infarction, within 40 days prior to enrollment * Subject underwent coronary artery bypass g