Left vs Left Randomized 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.

Conditions

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

Interventions

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%.

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.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Virginia Commonwealth University

  collaborator OTHER

• Cleveland Clinic Florida

  collaborator OTHER

• East Carolina University

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Mihail G Chelu, MD, PhD · Baylor College of Medicine

• Kenneth A Ellenbogen, MD · Virginia Commonwealth University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-13

Primary Completion

2029-06-30

Completion

2029-06-30

FDA Device

Yes

Countries

• United States
• Canada

Study Locations