Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular… (NCT05015660) | Clinical Trial Compass
RecruitingNot Applicable
Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing
Canada1,300 participantsStarted 2022-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Time to cardiovascular death
Timeframe: 36 months
2
Time to first heart failure event
Timeframe: 36 months
3
Worsening LV end systolic volume index by 2 years
Timeframe: 24 months
Trial details
NCT IDNCT05015660
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre