NCT05015660

Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing

LEFT Bundle Pacing vs Standard Right Ventricular Pacing for Heart Failure

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

High burden right ventricular (RV) pacing has been shown to increase cardiovascular mortality, incidence of heart failure (HF), worsen left ventricular (LV) function and accelerate the development of atrial fibrillation (AF). High percentage ventricular pacing and wider paced QRS in the setting of normal baseline LV ejection fractions have consistently been shown to be independent risk factors for pacing-induced cardiomyopathy. Left bundle branch pacing (LBBP) has emerged as a potential alternative pacing mechanism that may avoid LV dyssynchrony and pacing-induced LV dysfunction by mimicking native electrical conduction.

Detailed description

We hypothesize that in patients with high degree AV block with anticipated ventricular pacing \>90%, and an EF \>35% patients undergoing LBBP will demonstrate a significantly lower number of the primary composite endpoint of cardiovascular death, heart failure events, and change in LVESVi as compared to standard RV pacing. Echos will be performed at baseline, 12, 24, and 36 months. NTproBNPs are performed at baseline and follow-up. There will be a core echo lab, and blinded adjudication of ECGs and events.

Conditions

• Pacemaker DDD
• Heart Block

Interventions

Type	Name	Description
DEVICE	Left bundle branch pacing lead	Implantation of a left bundle branch pacing lead via sheath, to perform selective or non-selective pacing
DEVICE	Right ventricular active fixation lead	Active fixation lead (standard)

Timeline

• Start date: 2022-09-01
• Primary completion: 2026-12-01
• Completion: 2030-01-01
• First posted: 2021-08-20
• Last updated: 2026-03-11

Locations

1 site across 1 country: Canada