Left vs. Left

Full Name

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 (RCT) (Left vs Left RCT) Protocol Number NCT05650658

Description

Purpose

This trial evaluates the effects of His or left bundle branch pacing (LBBP) comparative to biventricular pacing on quality of life, exercise capacity, hospitalization for heart failure, and mortality in patients with heart failure and conduction system disease

Description

The Left vs Left study is a multi-center, international, randomized clinical trial comparing His or Left bundle branch pacing (His/LBBP) with biventricular pacing (BiVP) using a left ventricular epicardial lead in patients with heart failure (HF) and an indication for cardiac resynchronization therapy (CRT) according to current heart failure and pacing guidelines.

The entire study is designed with participants at the heart of care continuum. Participant goals and values are top priority in this study. The outcomes were designed to address issues that are important to participant. The results with regards to the participant-centered outcomes and complications will inform participants and their physicians on the most favorable strategy for participants with heart failure and conduction system disease requiring significant amount of pacing.

Eligibility

Inclusion Criteria

Inclusion Criteria-including but may not be limited to:

Men and women 18 years of age or older.
A LVEF ≤ 50% within 6 months prior to enrollment.
Resting QRS duration ≥ 130 ms on ECG.
Anticipated right ventricular pacing > 40% OR Device in place with right ventricular pacing > 40%.
Optimized on heart failure guideline directed medical therapy.