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.
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.
Women who are pregnant, lactating, or plan to become pregnant during the course of the trial.
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.
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.
Parallel
His/LBBP
DevicePacing at the level His-Bundle or left bundle branch is used to correct the underlying conduction abnormality, resulting in a faster and more homogeneous activation of the heart pacing directly via the intrinsic conduction system of the heart accompanied by a right atrial endocardial lead and a right ventricular defibrillator endocardial lead for LVEF≤35% and by a right atrial endocardial lead for LVEF 36-50%.
BiVP
DeviceBiventricular pacing has been shown to improve outcomes by delivering synchronized electrical stimuli to the right and left ventricles utilizing an an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus. For LVEF≤35% a biventricular pacemaker-defibrillator will be implanted while for LVEF 36-50% a biventricular pacemaker will be implanted.
A combined clinical endpoint of all-cause mortality and hospitalization for heart failure
The primary efficacy outcome will be described using Kaplan-Meier freedom from event curves over time, with event-free survival compared between assigned treatment arms using a logrank test, stratified by levels of the two factors (LVEF (≤35% vs. 36 to 50%) and conduction abnormality (LBBB vs non-LBBB)) used for randomization.
Assess change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at 12 months
Assess change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) item score measured before and at 12 months after implant.
Change in composite endpoint comprised of death, first hospitalization for worsening HF and left ventricular end systolic volume index (LVESVi) at 5.5 years
Secondary endpoint measured from all cause death, first hospitalization for heart failure and echocardiography on left ventricular end-systolic volume index (LVESVi) in the His/LBBP vs. BIV-BiVP arm
Composite of cardiovascular death or heart transplant or durable left ventricular assist device or more > 15% increase in the LVESVi or change in KCCQ-12 at the end of the study using win ratio
Secondary endpoint measured from cardiovascular death or heart transplant or durable left ventricular assist device or more \> 15% increase in the LVESVi or change in KCCQ-12 at the end of the study using win ratio
Death from any cause at 5.5 years
Secondary endpoint measured from all cause death
Appropriate ICD therapy for ventricular arrhythmias
Antitachycardia pacing or ICD shocks
Incidence of atrial tachyarrhythmia events
Atrial arrhythmia event measured through cIED
Change in Left Ventricular Ejection Fraction (LVEF) at 12 months
Measurement of LVEF before and at 12 months after implant using echocardiography
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Baylor College of Medicine
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
University of Utah
Collaborator
Virginia Commonwealth University
Collaborator
Cleveland Clinic Florida
Collaborator
East Carolina University
Collaborator
