Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anato
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 tomograph
| Condition(s) | Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 p |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | XSpline S.p.A. |
| Locations | Chicago, Illinois, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Durham, North Carolina, United States; Linz, Austria; Budapest, Hungary (+7 more sites) |
| Start date | 2023-03-06 |
| NCT ID | NCT05327062 |
| Official listing | https://clinicaltrials.gov/study/NCT05327062 |