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

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.

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
  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)

Primary outcome measures

• Time to cardiovascular death [Time frame: 36 months]
• Time to first heart failure event [Time frame: 36 months]
• Worsening LV end systolic volume index by 2 years [Time frame: 24 months]

Secondary outcome measures (11)

• Cardiovascular mortality [Time frame: 24 months]
• New visit for Heart Failure [Time frame: 24 months]
• Total mortality [Time frame: 24 months]
• Change in left ventricular ejection fraction [Time frame: 24 months]
• Change in NTproBNP level [Time frame: 24 months]
• Atrial fibrillation progression [Time frame: 24 months]
• Development of new tricuspid regurgitation [Time frame: 24 months]
• Presence of Mitral regurgitation [Time frame: 24 months]
• Change in Lead parameter [Time frame: 24 months]
• Quality of Life Improvement [Time frame: Evaluated at 1, 12, and 24 months, measure as compared to baseline]
• Safety of procedure and long-term safety [Time frame: 24 months]

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
• Pregnancy
• Patients in whom the conduction system abnormality is expected to be transient or recover over time
• Patients with permanent atrial fibrillation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• McGill University Health Centre-Research Institute — Montreal

Identifiers

NCT: NCT05015660 · 2021-7452

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗