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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Left bundle branch pacing lead

    Device

    Implantation of a left bundle branch pacing lead via sheath, to perform selective or non-selective pacing

  • Right ventricular active fixation lead

    Device

    Active fixation lead (standard)

Treatment groups

1,300 Participants
are divided into 2 treatment groups
Group A: left bundle branch pacingExperimental treatment 1 intervention
Group B: Right ventricular pacingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to cardiovascular death

Clinical

Time frame
36 months
2

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%

Time frame
36 months
3

Worsening LV end systolic volume index by 2 years

Defined as a 15% increase from baseline each year up to the two-year echo

Time frame
24 months

Secondary outcomes

1

Cardiovascular mortality

CV-related

Time frame
24 months
2

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.

Time frame
24 months
3

Total mortality

Total mortality

Time frame
24 months
4

Change in left ventricular ejection fraction

Echo parameter, change from baseline to 24 months

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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