Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021. A common complication following TAVI is traumatic atrioventricular block requiring pacemaker implantation, occurring in about 10% of patients. Conventional right ventricular pacing in these cases often leads to interventricular dyssynchrony, which can impair left ventricular ejection fraction and increase the risk of hospitalization, heart failure, and mortality.
Cardiac resynchronization therapy via biventricular pacing is sometimes proposed as a secondary intervention but involves additional surgery. A newer pacing technique-selective left bundle branch area pacing-has been developed to provide physiological ventricular activation by stimulating conduction pathways distal to the lesion, thereby avoiding dyssynchrony. Retrospective studies suggest clinical benefits, but no prospective randomized trial has yet evaluated its efficacy compared to standard pacing.
The objective of this study is to conduct the first randomized clinical trial comparing left bundle branch area pacing versus conventional right ventricular pacing in patients requiring pacemaker implantation due to atrioventricular block after TAVI.
Patients who have undergone TAVI for severe aortic valve disease within the past 3 months
Preserved left ventricular ejection fraction (LVEF ≥ 50%)
Third-degree atrioventricular (AV) block
Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1
Left ventricular ejection fraction (LVEF) < 50% before TAVI
Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis)
Previously implanted pacemaker
Patients under legal guardianship, curatorship, or judicial protection
Parallel
Pacemaker implantation using left bundle branch area stimulation
Procedure/SurgeryPacemaker implantation using left bundle branch area stimulation
Right ventricular pacemaker implantation
Procedure/SurgeryRight ventricular pacemaker implantation
number of cardiovascular deaths
number of hospitalizations for heart failure
number of surgical reinterventions
success rate of the LBAP technique
Verification of ECG effectiveness criteria: for the LBAP group: qR or rsR' appearance and for the RVP group: QS or rS aspect
comparison of immediate and long-term complications of the LBAP stimulation
Adverse events such as: pneumothorax, infection of equipment, displacement of atrial catheter, lumen haematoma, venous thrombosis, pericardial effusion, reoperation, vascular complication, catheter-specific complications
ECG measurements
QRS duration (ms)
left ventricular function (LVEF)
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