Comparison of left bundle branch area versus right ventricular septal pacing in patients with high-degree conduction disease after transcatheter aortic valve replacement: Left Bundle BRAVE study

The primary objective of this study is to investigate the superiority of chronic LBBAP compared to traditional right ventricular (RV) septal pacing in patients with high-degree conduction disease after transcatheter aortic valve replacement (TAVR). All patients enrolled in this study, have undergone TAVR within 2 weeks, developed high-grade conduction disease, deemed a candidate for pacemaker implantation, have left ventricular ejection fraction (LVEF) = 50% and have no independent indication for biventricular pacemaker implantation. This benefit will be demonstrated by assessing ejection fraction and left ventricular global longitudinal strain after 9 months of pacing in each pacing configuration (RV septal pacing vs LBBA pacing). Secondary endpoints are discussed below and include measures of clinical status, echocardiographic evaluation of left ventricular function and mechanical synchrony, and LBBAP function and stability. The first primary endpoint to be tested is the average difference in global longitudinal strain (LVGLS%), measured after 9 months of each pacing mode. This endpoint will be tested for superiority (LBBAP vs RV pacing) using a 1-sided hypothesis test at the 2.5% significance level. The second primary endpoint is the average difference in left ventricular ejection fraction (LVEF%), measured after 9 months of each pacing mode. This endpoint will be tested for superiority (LBBAP vs RV pacing) using a 1-sided hypothesis test at the 2.5% significance level.

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Medical Research
• Age: - 99 Years
• Gender: All