Left vs Left Randomized Clinical Trial

Heart Failure Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05650658
• Study type: Interventional
• Source: Baylor College of Medicine
• Contact: Mihail G Chelu, MD, PhD
• Phone: 7137987291
• Email: leftvsleft@bcm.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Completion date: June 30, 2029