Clinical Research Directory

LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI

Patients with new-onset complete LBBB (QRS \> 120 ms, persisting \> 24 h after TAVI) and moderately reduced LVEF (35-50%) will be screened in participating centers. Eligible patients will be centrally randomized 1:1 (stratified by center and atrial fibrillation (yes/no)) to either: * Experimental arm: Left bundle branch area pacing (LBB(AP)) with Biotronik pacemaker and dedicated conduction system pacing leads. * Control arm: Implantable loop recorder (ILR, Biotronik BIOMONITOR IV) for rhythm monitoring. The occurrence of the following events within 12 months of randomization will be evaluated: hospitalization for heart failure, syncope or hemodynamically significant dizziness, or high-grade atrioventricular conduction disturbance. The impact of LBB(AP) compared to ILR monitoring will be evaluated at 6, 12, 24, and 36 months regarding: incidence of atrial fibrillation; incidence of non-sustained ventricular tachycardia; evolution of left ventricular ejection fraction; quality of life; hospitalizations; mortality; medico-economic outcomes; qccurrence of high-grade AV conduction disorders beyond 12 months; omplications related to pacemaker or ILR implantation; unscheduled pacemaker implantation in the ILR group. Patients will be monitored following a regular schedule that includes clinical visits, transthoracic echocardiography , ECG, remote device monitoring, and EQ-5D at 6, 12, 24 and 36 months.