About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Patients with an ejection fraction of >35%
Third degree AV block
Symptomatic or asymptomatic second-degree AV block
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Left bundle branch pacing lead
DeviceImplantation of a left bundle branch pacing lead via sheath, to perform selective or non-selective pacing
Right ventricular active fixation lead
DeviceActive fixation lead (standard)
Treatment groups
Trial outcomes
Primary outcomes
Time to cardiovascular death
Clinical
Time to first heart failure event
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 volume index by 2 years
Defined as a 15% increase from baseline each year up to the two-year echo
Secondary outcomes
Cardiovascular mortality
CV-related
New visit for Heart Failure
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
Total mortality
Change in left ventricular ejection fraction
Echo parameter, change from baseline to 24 months
Sponsors and contacts
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McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
Heart and Stroke Foundation of Canada
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator