Evaluating Cardiac Resynchronization Therapy Using Biventricular or Left Bundle Branch Pacing in Patients with New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation with Mildly Reduced Heart Function

What this Trial Is About

Researchers are evaluating the effect of Cardiac Resynchronization Therapy CRT in patients who develop new and persistent Left Bundle Branch Block LBBB after Transcatheter Aortic Valve Implantation TAVI and have a moderately reduced left ventricular function with an ejection fraction between 35% and 55%. The study aims to see if early CRT implantation after TAVI can improve heart muscle function and reduce hospitalizations and mortality related to heart failure within one year. This is a prospective, randomized, multicenter, open-label interventional trial sponsored by Semmelweis University Heart and Vascular Center. Participants will be randomly assigned to receive either CRT implantation or standard care without intervention. CRT implantation involves placing a device in patients with new LBBB wider than 130 milliseconds after TAVI and mildly reduced heart function. The study compares outcomes between those receiving CRT and those receiving usual care to assess the therapys impact on heart remodeling and clinical events. During the study, participants will be closely monitored with echocardiography and clinical evaluations starting from postoperative day 5 to confirm eligibility and assess heart function. The primary outcome is measured at 12 months, focusing on heart failure-related hospitalizations and mortality. Participants will be followed to observe changes in heart function and any adverse events. The total participation duration includes the initial implantation and a one-year follow-up period.

Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation