Randomized Assessment of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Post-TAVR Patients With Persistent High-Degree Atrioventricular Block or Complete Heart Block Requiring Permanent Pacemaker Implantation

CV Mortality and Heart Failure Events

时间窗: from enrollment to the 12 month FU at minimum, with data collected every 6 months after until study completion at 5 year mark

The primary outcome of the full-scale RCT is a composite of CV mortality and HF events. All deaths and in-patient/outpatient unscheduled encounters will be adjudicated by a clinical events adjudication committee. HF events are defined as an admission to a healthcare facility for \>24 hours with a diagnosis of worsening HF or worsening HF requiring intravenous HF therapy and ultrafiltration at an urgent or outpatient healthcare facility. The rationale for using CV mortality and HF events as the primary outcome is that pacing therapy will not prevent non-CV deaths. The rationale for including the worsening of HF managed in outpatient facilities is that more patients are managed aggressively with IV diuretics in emergency departments, HF clinics, and infusion centers, avoiding hospitalization. This is accepted by Health Canada, US Food and Drug Administration, and European Medicines Agency.

Successful Enrollment and Randomization

时间窗: from start of enrollment to end of vanguard/pilot phase of study, enrolling 60 patients

(1) Successfully enroll and randomize 60 patients in 9 months from 6 participating centers

VANGUARD - Successful implantation of devices

时间窗: Vanguard phase - from enrollment to the 60th patient being enrolled and followed up at 12 month FU point

(2) Successfully implant the devices in 60 randomized patients, defined as \<10% inability to implant LBBAP lead in those randomized to have LBBAP

VANGUARD - at least 90% ventricular pace at 3 months follow up

时间窗: enrollment to 3 month FU timepoint

\>90% ventricular pace in these 60 patients at 3 months follow-up