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Europace 2006 8(1):76-80; doi:10.1093/europace/euj020
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

PACING

Biventricular vs. left univentricular pacing in heart failure: rationale, design, and endpoints of the B-LEFT HF study

Christophe Leclercq1,*, Gerardo Ansalone2, Fredrik Gadler3, Giuseppe Boriani4, Nicasio Perez-Castellano5, Neil Grubb6, Stefan Sack7 and Eric Boulogne8

Department of Cardiology, Rennes University Hospital CHU Pontchaillou, 2, rue Henri Le Guilloux,Cedex 9, 35033 Rennes France ; Department of Cardiology, Madre G. Vannini Hospital Rome Italy ; Department of Cardiology, Karolinska Hospital Stockholm Sweden ; Institute of Cardiology, University of Bologna, San Orsola Malpighi Hospital Bologna Italy ; Arrhythmias Unit, Hospital San Carlos Madrid Spain ; Cardiovascular Research Unit, Royal Infirmary Edinburgh UK ; Department of Cardiology, University Hospital Essen Germany ; EMEA Clinical Department, St Jude Medical Zaventem Belgium

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.

Key Words: Heart failure, Cardiac dyssynchrony, Cardiac resynchronization therapy, Left ventricular pacing, Biventricular pacing, Clinical trial

Corresponding author. Tel: +33 2 99 28 25 25; fax: +33 2 99 28 25 10. E-mail address:christophe.leclercq{at}chu-rennes.fr


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