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This is a multicenter, randomized controlled study. This study aims to compare the clinical efficacy of LBBAP with traditional biventricular pacing in patients with permanent atrial fibrillation and heart Failure
Full description
LBBAP-AFHF is a prospective, multicenter, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may show superiority of improved LV function as compared with traditional biventricular pacing (BiVP) in patients with permanent atrial fibrillation and heart failure (LVEF<50%) who receive atrioventricular nodal ablation due to fast ventricular rate or require high percentage of ventricular pacing due to slow ventricular rate. The primary endpoint of this trial is the change in the LVEF at 6 months after device implantation from baseline. A CRT-P/D device would be implanted and LBBAP lead would be connected to the RA port and LV lead to the LV port. Patients who receive successful LBBAP and BiVP simultaneously during the procedure would be 1:1 randomized to LBBAP or BiVP group after the procedure by device programming. Patients will be followed at 3 and 6 months post-discharge for LVEF and other echographic parameters (including LVESV, response rate), and rehospitalization for heart failure or all-cause death.
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Inclusion criteria
Adult patients aged more than 18 years old
Patients diagnosed with heart failure (LVEF<50%) and have received optimal medical therapy for at least 3 months
Patients with permanent atrial fibrillation (QRS duration <130ms) which need ventricular pacing, including:
Written informed consent was provided
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60 participants in 2 patient groups
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Central trial contact
Xiaofei Li, M.D; Haojie Zhu, M.D
Data sourced from clinicaltrials.gov
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