Overview
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
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 graft or valve surgery, within 90 days prior to enrollment
- 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
- Subject is implanted with a left ventricular assist device
- Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
- Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
- Subject has congenital heart disease
- Subject has a mechanical right-sided heart valve
- Subject has a life expectancy of less than one year in the opinion of the investigator
- Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
- Subject is enrolled in one or more concurrent studies that would confound the results of this study
- Patients who have contraindications to CT scanning.
- Patients with chronic kidney diseases and estimated glomerular filtration rate (eGMR) calculated based on CKD-EPI 2009 < 40 ml/min/1.73m2