Leclercq Christophe, Ansalone Gerardo, Gadler Fredrik, Boriani Giuseppe, Perez-Castellano Nicasio, Grubb Neil, Sack Stefan, Boulogne Eric
Department of Cardiology, Rennes University Hospital CHU Pontchaillou, 2, rue Henri Le Guilloux, Cedex 9, 35033 Rennes, France.
Europace. 2006 Jan;8(1):76-80. doi: 10.1093/europace/euj020.
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.
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).
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.
心脏再同步治疗（CRT）为因心室不同步相关的收缩功能障碍而患有充血性心力衰竭（CHF）的患者带来持续的治疗益处。迄今为止，双心室（BiV）起搏一直是首选方法，因为它能纠正电和机械不同步。仅左心室（LV）起搏在前期研究中也显示出类似益处，可能是一种替代治疗方法。“心力衰竭患者双心室与仅左心室起搏加植入式心脏除颤器（ICD）备用”（B-LEFT HF）是一项国际、前瞻性、随机、平行设计、双盲临床试验，旨在研究仅LV起搏在CHF患者中是否与BiV起搏一样安全有效。
该试验将把172名患者随机分配至仅LV起搏组或BiV起搏组。该研究前瞻性地定义了在6个月时评估的疗效终点，即（i）功能能力变化和逆向重塑程度（主要终点）以及（ii）心力衰竭临床综合反应变化（次要终点）。
由于CRT中仅LV起搏在技术上可能比BiV起搏挑战性更小且成本更低，因此需要一项专门设计的研究来比较这两种配置的安全性和有效性。B-LEFT HF试验旨在解决这一关键问题。
