Clinical trial NCT05015660: Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing
Official title: LEFT Bundle Pacing vs Standard Right Ventricular Pacing for Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pacemaker DDD
Heart Block
Keywords: left bundle branch pacing
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-08-20
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective open-label randomized controlled trial (1:1) with blinded outcome adjudication
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to cardiovascular death
timeFrame: 36 months
measure: Time to first heart failure event
timeFrame: 36 months
measure: Worsening LV end systolic vloume index at 2 years
timeFrame: 24 months
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 24 months
measure: New visit for Heart Failure
timeFrame: 24 months
measure: Total mortality
timeFrame: 24 months
measure: Change in left ventricular ejection fraction
timeFrame: 24 months
measure: Change in NTproBNP level
timeFrame: 24 months
measure: Atrial fibrillation progression
timeFrame: 24 months
measure: Development of new tricuspid regurgitation
timeFrame: 24 months
measure: Presence of Mitral regurgitation
timeFrame: 24 months
measure: Change in Lead parameter
timeFrame: 24 months
measure: Quality of Life Improvement
timeFrame: Evaluated at 1, 12, and 24 months, measure as compared to baseline
measure: Safety of procedure and long-term safety
timeFrame: 24 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre-Research Institute
state: Quebec
Study officials:
References: