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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
266
Pacemaker implantation using left bundle branch area stimulation
Right ventricular pacemaker implantation
Brest University Hospital
Brest, Finistère, France
NOT_YET_RECRUITINGRennes University Hospital
Rennes, Ille-et-Vilaine, France
NOT_YET_RECRUITINGTours University Hospital
Tours, Indre-et-Loire, France
NOT_YET_RECRUITINGNantes University Hospital
Nantes, Loire-Atlantique, France
RECRUITINGClermont Ferrand University Hospital
Clermont-Ferrand, Puy-de-Dôme, France
NOT_YET_RECRUITINGRouen University Hospital
Rouen, Seine-Maritime, France
NOT_YET_RECRUITINGPoitiers University Hospital
Poitiers, Vienne, France
NOT_YET_RECRUITINGnumber of cardiovascular deaths
Time frame: 24 months
number of hospitalizations for heart failure
Time frame: 24 months
number of surgical reinterventions
Time frame: 24 months
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
Time frame: 3, 12, and 24 months post-implantation
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
Time frame: 3, 12, and 24 months post-implantation
ECG measurements
QRS duration (ms)
Time frame: 3, 12, and 24 months post-implantation
left ventricular function (LVEF)
Time frame: 3, 12, and 24 months post-implantation
left ventricular diameter
Time frame: 3, 12, and 24 months post-implantation
creatinine levels
Time frame: 3, 12, and 24 months post-implantation
GFR in CKD EPI
Time frame: 3, 12, and 24 months post-implantation
Comparison of the occurrence of atrial fibrillation and ventricular tachycardia (non-sustained or sustained), based on pacemaker monitoring data.
Time frame: 3, 12, and 24 months post-implantation
EQ-5D-5L questionnaire.
Time frame: Baseline (inclusion), 3, 12, and 24 months post-treatment
Evaluate the cost-effectiveness of left bundle branch area pacing versus standard therapy in this population using a cost-utility analysis.
This will be calculated from EQ-5D-5L utility scores.
Time frame: 24 months post-implantation
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