LEFT-HF

LEFT Bundle Pacing vs Standard RV Pacing for Heart Failure

Objective

The LEFT HF study is a multi-centre randomized double-blinded controlled trial of two treatment groups. Eligible patients will have an LVEF of > 35% and a standard bradycardia indication for RV pacing where the projected percent of ventricular pacing is >90%. Subjects will be randomized (1:1) to either the control arm (RV pacing) or the experimental arm (LBBP). Patients will then be stratified by centre. Enrolled subjects will undergo implantation using Health Canada approved devices. Patients will be followed up at 6, 12, 24, and 36 months in the device clinic with pacemaker interrogations and electrocardiograms and will undergo a transthoracic echocardiogram at baseline, 12 and 24, and 36 month time points. An NTproBNP blood test will be performed at baseline, 24, and 36 months. Quality of Life questionnaires will be administered at baseline, 12 months, 24, and 36 months (36-Item Short Form Survey (SF-36), Aquarel, and Minnesota Living with Heart Failure Questionnaire (MLHFQ)).

  1. Inclusion

    • 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, but not limited to:
      • 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), and
    • Echocardiogram within the last 3 months, with ability to obtain DICOM images

  2. Exclusion

    • Indication for an implantable cardioverter defibrillator
    • Presence of a mechanical tricuspid valve
    • Any prior attempt at implantation of an implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP)
    • Lack of capacity to consent
    • Other serious medical condition with life expectancy of <2 years
    • Pregnancy or intention to become pregnant during the trial period
    • Patients in whom the conduction system abnormality is expected to be transient or recover over time
    • Patients with permanent atrial fibrillation
Enrolling

Additional Info

Ethics ID: REB23-1591

ClinicalTrials.gov ID: NCT05015660

 

Sponsor: Research Institute of the McGill University Health Centre (MUHC-RI)

 

PI: Dr. Derek Chew

 

Admin: Jennifer McKeage

Phone: 403 210 6047

Email: jmckeage@ucalgary.ca 

Updated Apr 21, 2024

ICF