LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant for advanced (2° or 3° degree) atrioventricular block, with baseline left ventricular ejection fraction (LVEF) \>45%.
LEAP-CAR is a randomized, prospective, double blind clinical trial.
advanced AVB (frequent 2° degree or 3° degree AVB, atrial fibrillation - AF - with advanced AV block) and preserved or slightly reduced LVEF (>45%)
LVEF ≤45%
signs or symptoms of heart failure at enrollment
unstable angina or acute coronary syndrome <3 months
percutaneous coronary intervention or coronary-artery bypass surgery <3 months
Parallel
Left bundle branch area pacing (LBBAP)
DevicePacing of the conduction system of the heart to obtain physiological activation
Right ventricular pacing (RVP)
DeviceConventional ventricular pacing
Absolute and relative value of LVEF (left ventricular ejection fraction) difference between two arms at follow-up
comparison of LVEF by transthoracic echocardiography at 12 months between the two arms (LBBAP vs RV pacing).
success rate
Percentages of unsuccessful procedure in the two arms (LBBAP vs RV pacing)
Distance covered at 6'WT (meters)
Comparison of distance covered at 6'WT at 12 months between the two arms (LBBAP vs RV pacing)
Score of quality of life (n: Higher value = worst outcome)
Comparison of MLHFQ score at 12 months between the two arms (LBBAP vs RV pacing)
Intra-patient evolution of LVEF
Comparison of variation in LVEF (absolute and %) from baseline to 12 months in the two arms (LBBAP and RV pacing, baseline vs 12 months follow up)
Heart failure hospitalization and mortality
any hospitalization for heart failure or starting of medications for heart failure or mortality
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