NCT05015660

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Sep 2022Jan 2030

First Submitted

Initial submission to the registry

August 10, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

4.3 years

First QC Date

August 10, 2021

Last Update Submit

March 9, 2026

Conditions

Pacemaker DDDHeart Block

Keywords

left bundle branch pacing

Outcome Measures

Primary Outcomes (3)

  • Time to cardiovascular death

    Clinical

    36 months

  • 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%

    36 months

  • Worsening LV end systolic volume index by 2 years

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

    24 months

Secondary Outcomes (11)

  • Cardiovascular mortality

    24 months

  • New visit for Heart Failure

    24 months

  • Total mortality

    24 months

  • Change in left ventricular ejection fraction

    24 months

  • Change in NTproBNP level

    24 months

  • +6 more secondary outcomes

Study Arms (2)

left bundle branch pacing

EXPERIMENTAL
Device: Left bundle branch pacing lead

Right ventricular pacing

ACTIVE COMPARATOR
Device: Right ventricular active fixation lead

Interventions

Right ventricular active fixation leadDEVICE

Active fixation lead (standard)

Right ventricular pacing
Left bundle branch pacing leadDEVICE

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

left bundle branch pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre-Research Institute

Montreal, Quebec, H3Y2T6, Canada

RECRUITING

MeSH Terms

Conditions

Heart Block

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jacqueline Joza, MD MSc

CONTACT

514-934-1934jacqueline.joza@gmail.com

Fiorella Rafti, PhD

CONTACT

514-934-1934fiorella.rafti@mail.mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded outcome adjudication
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective open-label randomized controlled trial (1:1) with blinded outcome adjudication
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiac electrophysiologist

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 20, 2021

Study Start

September 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2030

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

CA(1)