Randomized Trial Comparing HisLeft Bundle Branch Pacing Versus Biventricular Pacing in Adults with Heart Failure and Reduced Left Ventricular Ejection Fraction

What this Trial Is About

This research aims to compare two pacing methods, His or Left bundle branch pacing HisLBBP and biventricular pacing BiVP, in patients with heart failure caused by left ventricular systolic dysfunction LVEF 50% who have either a wide QRS duration 130 ms or requireanticipate more than 40% pacing. The study focuses on patient-centered outcomes such as quality of life, physical activity, hospitalizations for heart failure, mortality, and device-related complications like lead dislodgement and infection, while participants continue standard heart failure medication. Participants are randomly assigned to receive either HisLBBP or BiVP devices. For patients with LVEF 35%, the HisLBBP group receives a defibrillator with three implanted leads, including a His-bundle or left bundle branch pacing lead, while those with LVEF 36-50% receive a pacemaker with two leads. The BiVP group receives a defibrillator with three leads for LVEF 35% and a pacemaker with three leads, including an epicardial left ventricular lead, for LVEF 36-50%. The pacing devices aim to synchronize heartbeats through different approaches to improve heart function. Throughout the study, participants are monitored for up to 5.5 years. Researchers will assess combined outcomes of all-cause death and heart failure hospitalizations as the primary measure. Secondary assessments include quality of life changes, psychological adjustment at one year, and heart function measured by left ventricular volume changes. Patient activity and heart failure symptoms will also be tracked using questionnaires, walk tests, and implanted device data. Safety and complications related to the devices will be closely followed during the study period.

Left vs Left Randomized Clinical Trial