Biventricular vs. left univentricular pacing in heart failure: rationale, design, and endpoints of the B-LEFT HF study.
AIMS: Cardiac resynchronization therapy (CRT) confers sustained therapeutic benefits to patients suffering from congestive heart failure (CHF) due to systolic dysfunction associated with ventricular dyssynchrony. Biventricular (BiV) pacing has, thus far, been the preferred method, as it corrects both electrical and mechanical dyssynchrony. Left ventricular (LV) only pacing, which has conferred similar benefits in pilot studies, may be an alternative treatment method. 'Biventricular vs. left univentricular pacing with ICD back-up in heart failure patients' (B-LEFT HF) is an international, prospective, randomized, parallel-design, double-blind, clinical trial to examine whether LV only pacing is as safe and effective as BiV pacing in patients suffering from CHF. METHODS AND RESULTS: The trial will randomly assign 172 patients to either LV only or BiV pacing. The study has prospectively defined efficacy endpoints to be evaluated at 6 months, which are (i) changes in functional capacity and degree of reverse remodelling (primary) and (ii) changes in the heart failure clinical composite response (secondary). CONCLUSION: Because LV only pacing in CRT is likely to be technically less challenging and costly than BiV, a specifically designed study is needed to compare the safety and effectiveness of the two configurations. B-LEFT HF has been designed to settle this critical issue.