Compares two pacing methods for heart failure with reduced heart function
Tests His or left bundle branch pacing against biventricular pacing in heart failure patients.
Plain-language title generated from the registry record
Registry title: Left vs Left Randomized Clinical Trial
Key facts
- Where
- Calgary, Edmonton, Halifax, Hamilton, Kitchener, Montreal, Newmarket, Ottawa, Québec, Saint-Jean-sur-Richelieu, Toronto, Vancouver, and Victoria, CanadaSee the 14 sites
Where in Canada
- University Of CalgaryCalgary, CanadaTaking people
- Mazankowski Alberta Heart Institute/University of AlbertaEdmonton, CanadaNot yet recruiting
- Nova Scotia Health AuthorityHalifax, CanadaTaking people
- Hamilton Health Sciences (HHS)Hamilton, CanadaTaking people
- Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General HospitalKitchener, CanadaTaking people
- Montreal Heart InstituteMontreal, CanadaTaking people
- Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General HospitalMontreal, CanadaTaking people
- Newmarket Electrophysiology Research Group Inc. (NERG)Newmarket, CanadaTaking people
- University of Ottawa Heart InstituteOttawa, CanadaTaking people
- Universite LavalQuébec, CanadaTaking people
- CIUSSS de l'Estrie - CHUSSaint-Jean-sur-Richelieu, CanadaNot yet recruiting
- Sunnybrook Research InstituteToronto, CanadaTaking people
- University of British ColumbiaVancouver, CanadaTaking people
- Victoria Cardiac Arrhythmia Trials (VCAT) Inc.Victoria, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Baylor College of Medicine
- Trial code
- NCT05650658
- Record updated
- 2 October 2025
- Original description
The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy.Read full original descriptionShow less
Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing With a Left Ventricular Epicardial Lead in Patients With Heart Failure (HF) With Left Ventricular Ejection Fraction (LVEF)≤50% and With Either a Wide QRS Complex (>130 ms) or With/Anticipated >40% Pacing Randomized Clinical Trial
The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy.
Inclusion: Men and women 18 years of age or older; A LVEF ≤ 50% within 6 months prior to enrollment; Resting QRS duration ≥130 ms as evidenced by a historical 12-lead ECG prior to enrollment OR anticipated right ventricular pacing >40% OR device in place with right ventricular pacing > 40%; Are optimized on HF guideline directed medical therapy according to current HF published guidelines OR patient's physician will make an effort to start all guideline-directed medical therapy and titrate doses up as permitted by the participant clinical status and co-morbidities prior to implantation procedure.
Exclusion: Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment; Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment; Participants who had any prior unsuccessful attempt at implantation of biventricular pacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device; Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months; Participants with Chagas disease, cardiac sarcoidosis or amyloidosis; Expected to receive left ventricular assist device or heart transplantation within 6 months; Participants with primary severe valvular disease (e.g., aortic stenosis); Participants with irreversible brain damage from preexisting cerebral disease; Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine; Women who are pregnant, lactating, or plan to become pregnant during the course of the trial; Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis); Have a life expectancy of less than 12 months; Participants participating in any other interventional cardiovascular clinical trial; Participants who would be unable to comply with the study's follow-up visit schedule; or.