Comparing left bundle branch pacing to standard right ventricular pacing
LEFT Bundle Pacing vs Standard Right Ventricular Pacing for Heart Failure
This study tests if a new way of pacing the heart called left bundle branch pacing can help people with a serious heart condition live longer and feel better compared to the standard pacing method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05015660 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of left bundle branch pacing (LBBP) compared to standard right ventricular pacing (RVP) in patients with high-degree atrioventricular block. The study aims to determine if LBBP can reduce cardiovascular death, heart failure events, and changes in left ventricular size over time. Patients will undergo echocardiograms and NTproBNP tests at various intervals to monitor their heart function and health outcomes. The trial focuses on individuals who are expected to require significant ventricular pacing due to their heart condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with an ejection fraction greater than 35% and high-degree AV block requiring more than 90% ventricular pacing.
Not a fit: Patients who may not benefit include those with indications for an implantable cardioverter defibrillator or other serious medical conditions with a life expectancy of less than two years.
Why it matters
Potential benefit: If successful, this approach could lead to improved heart function and reduced cardiovascular risks for patients requiring pacemakers.
How similar studies have performed: While the approach of left bundle branch pacing is emerging, it is still relatively novel and has not been extensively tested in large-scale studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- McGill University Health Centre-Research Institute — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Jacqueline Joza, MD MSc
- Email: jacqueline.joza@gmail.com
- Phone: 514-934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.