Study of Personalized Cardiac Resynchronization Therapy Using Non-Invasive Electrical and Venous Mapping to Guide Lead Placement

What this Trial Is About

Researchers are evaluating a method to improve Cardiac Resynchronization Therapy CRT implantation by using a cloud-based pre-procedural roadmap. This roadmap integrates 3D images from electrical activation sequences and coronary venous anatomy obtained by non-invasive tests. The study aims to see if this approach can guide the placement of the left ventricular lead to areas of delayed electrical activation and reduce the hearts left ventricular end-systolic volume by at least 15% in 75% of patients six months after treatment. Participants will undergo CRT implantation guided by XSpline technology, which uses patient data including ECG, echocardiography, and computed tomography angiography. The imaging data are processed on a cloud platform to identify the best site for lead placement. The procedure follows local protocols with visual verification by X-ray to confirm lead position. The study includes at least 150 patients and compares the new approachs outcomes to previous CRT populations. During the study, participants will have their clinical and cardiovascular history recorded along with routine examinations and imaging tests. Researchers will monitor heart function changes, procedural time, and total X-ray exposure over six months. The main outcome measured is the reduction in left ventricular end-systolic volume. Safety and feasibility of the XSpline platform use for CRT implantation will also be assessed.

Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment