Comparing Conduction System Pacing and Biventricular Pacing for Adults Aged 18 to 80 with Heart Failure and Right Ventricular Pacing Upgraded to Cardiac Resynchronization Therapy

What this Trial Is About

Researchers are investigating whether conduction system pacing CSP is as effective as biventricular pacing BiVP in patients with heart failure and right ventricular pacing RVP who need upgrading to cardiac resynchronization therapy CRT. This prospective, multicenter, randomized controlled trial aims to compare these two pacing methods to see if CSP is not inferior to BiVP in improving heart function. Participants will be randomly assigned to one of two groups. The experimental group will receive CSP lead placement, starting with left bundle branch pacing LBBP and switching to His bundle pacing HBP if LBBP is unsuccessful. The control group will receive traditional biventricular pacing, involving placement of right atrial, right ventricular, and left ventricular leads using standard techniques. The study will monitor participants over six months to assess treatment effects. During the study, participants will undergo evaluations including echocardiography to measure changes in left ventricular ejection fraction LVEF, heart size, pacing parameters, and heart function classification. Additional assessments include quality of life questionnaires, walk distance tests, blood markers, and monitoring for adverse events and device-related complications at multiple time points up to six months. The primary outcome is the change in LVEF from baseline to six months after device implantation.

CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy