LEFT Bundle Pacing vs Standard Right Ventricular Pacing for Heart Failure
Overview
- Phase
- N/A
- Intervention
- Left bundle branch pacing lead
- Conditions
- Pacemaker DDD
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Enrollment
- 1300
- Locations
- 1
- Primary Endpoint
- Time to first heart failure event
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief 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.
Investigators
Jacqueline Joza
Cardiac electrophysiologist
McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Patients with an ejection fraction of \>35%
- •Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is \>90% including:
- •Third degree AV block
- •Symptomatic or asymptomatic second-degree AV block
- •First degree AV block ≥ 280ms with a narrow QRS, or ≥ 240ms with an intraventricular delay (QRS duration ≥120ms)
- •Echocardiogram within the last 3 months, with ability to have DICOM images
Exclusion Criteria
- •Indication for an implantable cardioverter defibrillator
- •Presence of a mechanical tricuspid valve
- •Any prior attempt at implantation of an ICD, CRT, HBP, or LBBP
- •Lack of capacity to consent
- •Other serious medical condition with life expectancy of \<2 years
- •Patients in whom the conduction system abnormality is expected to be transient or recover over time
- •Patients with permanent atrial fibrillation
Arms & Interventions
left bundle branch pacing
Intervention: Left bundle branch pacing lead
Right ventricular pacing
Intervention: Right ventricular active fixation lead
Outcomes
Primary Outcomes
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%
Time to cardiovascular death
Time Frame: 36 months
Clinical
Worsening LV end systolic volume index by 2 years
Time Frame: 24 months
Defined as a 15% increase from baseline each year up to the two-year echo
Secondary Outcomes
- Cardiovascular mortality(24 months)
- Atrial fibrillation progression(24 months)
- Change in NTproBNP level(24 months)
- Development of new tricuspid regurgitation(24 months)
- Change in Lead parameter(24 months)
- New visit for Heart Failure(24 months)
- Presence of Mitral regurgitation(24 months)
- Quality of Life Improvement(Evaluated at 1, 12, and 24 months, measure as compared to baseline)
- Total mortality(24 months)
- Change in left ventricular ejection fraction(24 months)
- Safety of procedure and long-term safety(24 months)