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

Overview

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.

Full Title of Study: “LEFT Bundle Pacing vs Standard Right Ventricular Pacing for Heart Failure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 1, 2026

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.

Interventions

  • Device: Left bundle branch pacing lead (Select Secure 3830 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)

Arms, Groups and Cohorts

  • Experimental: left bundle branch pacing
  • Active Comparator: Right ventricular pacing

Clinical Trial Outcome Measures

Primary Measures

  • Time to cardiovascular death
    • Time Frame: 36 months
    • Clinical
  • Time to first heart failure event
    • Time Frame: 36 months
    • Defined as: (i) Emergency department (ED) visits or hospitalization for HF (requiring signs and symptoms consistent with congestive heart failure (CHF) that is responsive to oral or parenteral medications); (ii) intensification of therapy (intravenous diuretic therapy on an outpatient basis); or (iii) indication for device upgrade to CRT due to deteriorating LV function defined as an absolute decline in LVEF ≥ 10% from baseline and an LVEF ≤ 40%
  • Worsening LV end systolic vloume index at 2 years
    • Time Frame: 24 months
    • Defined as a 15% increase from baseline on the two-year echo

Secondary Measures

  • Cardiovascular mortality
    • Time Frame: 24 months
    • CV-related
  • New visit for Heart Failure
    • Time Frame: 24 months
    • Heart failure visit is defined as: i) Emergency department visit or hospitalization for signs and symptoms of HF that is responsive to oral or intravenous diuretics ii) intensification of therapy defined as outpatient intravenous diuretic therapy, and iii) device upgrade to cardiac resynchronization therapy.
  • Total mortality
    • Time Frame: 24 months
    • Total mortality
  • Change in left ventricular ejection fraction
    • Time Frame: 24 months
    • Echo parameter, change from baseline to 24 months
  • Change in NTproBNP level
    • Time Frame: 24 months
    • From baseline to 24 months
  • Atrial fibrillation progression
    • Time Frame: 24 months
    • Atrial fibrillation burden as noted on pacemaker
  • Development of new tricuspid regurgitation
    • Time Frame: 24 months
    • More than mild TR from baseline
  • Presence of Mitral regurgitation
    • Time Frame: 24 months
    • Progression/Development from baseline
  • Change in Lead parameter
    • Time Frame: 24 months
    • stability of impedance, sensing, thresholds
  • Quality of Life Improvement
    • Time Frame: Evaluated at 1, 12, and 24 months, measure as compared to baseline
    • Health related quality of life score: Short Form 12
  • Safety of procedure and long-term safety
    • Time Frame: 24 months
    • Procedural and long-term safety of left bundle pacing

Participating in This Clinical Trial

Inclusion Criteria

1. Age ≥ 18 years 2. Patients with an ejection fraction of >35% 3. Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is >90% including: 1. Third degree AV block 2. Symptomatic or asymptomatic second-degree AV block 3. First degree AV block ≥ 280ms with a narrow QRS, or ≥ 240ms with an intraventricular delay (QRS duration ≥120ms) 4. Echocardiogram within the last 3 months, with ability to have DICOM images Exclusion Criteria:

1. Indication for an implantable cardioverter defibrillator 2. Presence of a mechanical tricuspid valve 3. Any prior attempt at implantation of an ICD, CRT, HBP, or LBBP 4. Lack of capacity to consent 5. Other serious medical condition with life expectancy of <2 years 6. Pregnancy 7. Patients in whom the conduction system abnormality is expected to be transient or recover over time 8. Patients with permanent atrial fibrillation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Collaborator
    • Heart and Stroke Foundation of Canada
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jacqueline Joza, Cardiac electrophysiologist – McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Overall Contact(s)
    • Jacqueline Joza, MD MSc, 514-934-1934, jacqueline.joza@gmail.com

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