Left vs Left Randomized Clinical Trial

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.

Conditions

Heart Failure, Heart Failure With Reduced Ejection Fraction, AV Block, LBBB, RBBB, Intraventricular Conduction Delay, Pacing-Induced Cardiomyopathy

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Study Overview

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Study Details

Study overview

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.

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

Left vs Left Randomized Clinical Trial

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Chicago

Rush University, Chicago, Illinois, United States, 60612

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Scranton

Geisinger Commonwealth School of Medicine, Scranton, Pennsylvania, United States, 18510

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baylor College of Medicine,

Mihail G Chelu, MD, PhD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Kenneth A Ellenbogen, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

2029-06-30