NCT05015660 Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing
| NCT ID | NCT05015660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Pacemaker DDD |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,300 participants in total. It began in 2022-09-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05015660 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pacemaker DDD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05015660 currently recruiting?
Yes, NCT05015660 is actively recruiting participants. Contact the research team at jacqueline.joza@gmail.com for enrollment information.
Where is the NCT05015660 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05015660 clinical trial?
NCT05015660 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The trial plans to enroll 1,300 participants.