Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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. - Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis). - Participants with Chagas disease, cardiac sarcoidosis or amyloidosis. - Expected to receive left ventricular assist device or heart transplantation within 6 months. - Participants with severe valvular disease (e.g., aortic stenosis). - Have a life expectancy of less than 12 months. - 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. - Participants participating in any other interventional cardiovascular clinical trial. - Participants who would be unable to return for follow-up visits due to the distance from the clinic. - Participants who do not anticipate being a resident of the area for the scheduled duration of the trial.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
His/Left Bundle Branch Pacing (His/LBBP)
Patients with LVEF≤35% at entry will receive a His/LBB defibrillator which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular ICD lead, and an endocardial His-bundle or left bundle branch pacing lead directly pacing the intrinsic conduction system. Patients with LVEF 36-50% at entry will receive His/LBB pacemaker which includes implantation of two leads, an endocardial right atrial lead, and an endocardial His-bundle or left bundle branch pacing lead directly pacing the intrinsic conduction system.
  • Device: His/LBBP
    Pacing 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%.
Active Comparator
Biventricular Pacing (BiVP)
Patients with LVEF≤35% at entry will receive a BiV defibrillator which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular ICD lead, and and an epicardial left ventricular lead implanted in a branch of the coronary sinus. Patients with LVEF 36-50% at entry will receive BiV pacemaker which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular pacing lead, and and an epicardial left ventricular lead implanted in a branch of the coronary sinus.
  • Device: BiVP
    Biventricular 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.

Recruiting Locations

Rush University
Chicago, Illinois 60612
Contact:
Nusrat Jahan

University of Chicago
Chicago, Illinois 60637
Contact:
Shahram Sarrafi

Geisinger Commonwealth School of Medicine
Scranton, Pennsylvania 18510
Contact:
Grace E Hughes

Virginia Commonwealth University
Richmond, Virginia 23284
Contact:
Melissa Sears

More Details

NCT ID
NCT05650658
Status
Recruiting
Sponsor
Baylor College of Medicine

Study Contact

Mihail G Chelu, MD, PhD
7137987291
leftvsleft@bcm.edu

Detailed Description

In this prospective, randomized, multi-center clinical trial, the investigators aim to prospectively evaluate the comparative effectiveness His or Left bundle branch pacing (His/LBBP) vs. biventricular pacing (BiVP) 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 by assessing all cause death and heart failure hospitalization at the end of the study. Additional formal secondary objectives include evaluation disease-specific quality and psychological adjustment changes at 1 year after device implant and evaluation of a composite of death of any cause or heart failure hospitalization or more >15% increase in the left ventricular end-systolic volume index at the end of the study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.