Tomassoni Gery, Baker James, Corbisiero Raffaele, Love Charles, Martin David, Sheppard Robert, Worley Seth J, Lee Kwangdeok, Niazi Imran
Baptist Health Lexington, Lexington, KY, USA.
Saint Thomas Research Institute, Nashville, TN, USA.
Ann Noninvasive Electrocardiol. 2017 Nov;22(6). doi: 10.1111/anec.12448. Epub 2017 May 18.
Although the majority of Class III congestive heart failure (HF) patients treated with cardiac resynchronization therapy (CRT) show a clinical benefit, up to 40% of patients do not respond to CRT. This paper reports the design of the MultiPoint Pacing (MPP) trial, a prospective, randomized, double-blind, controlled study to evaluate the safety and efficacy of CRT using MPP compared to standard biventricular (Bi-V) pacing.
A maximum of 506 patients with a standard CRT-D indication will be enrolled at up to 50 US centers. All patients will be implanted with a CRT-D system (Quartet LV lead Model 1458Q with a Quadra CRT-D, Abbott) that can deliver both MPP and Bi-V pacing. Standard Bi-V pacing will be activated at implant. At 3 months postimplant, patients in whom the echocardiographic parameters during MPP are equal or better than during Bi-V pacing are randomized (1:1) to either an MPP or Bi-V arm.
The primary safety endpoint is freedom from system-related complications at 9 months. Each patient's response to CRT will be evaluated using a heart-failure clinical composite score, consisting of a change in NYHA functional class, patient global assessment score, HF events, and cardiovascular death. The primary efficacy endpoint is the proportion of responders in the MPP arm compared with the Bi-V arm between 3 and 9 months.
This trial seeks to evaluate whether MPP via a single quadripolar LV lead improves hemodynamic and clinical responses to CRT, both in clinical responders and nonresponders.
尽管大多数接受心脏再同步治疗（CRT）的Ⅲ级充血性心力衰竭（HF）患者显示出临床获益，但仍有高达40%的患者对CRT无反应。本文报告了多点起搏（MPP）试验的设计，这是一项前瞻性、随机、双盲、对照研究，旨在评估与标准双心室（Bi-V）起搏相比，使用MPP进行CRT的安全性和有效性。
最多506例有标准CRT-D适应症的患者将在美国多达50个中心入组。所有患者将植入一个CRT-D系统（带有Quadra CRT-D的1458Q型Quartet左心室导线，雅培公司），该系统能够进行MPP和Bi-V起搏。植入时激活标准Bi-V起搏。在植入后3个月，MPP期间超声心动图参数等于或优于Bi-V起搏期间的患者被随机（1:1）分为MPP组或Bi-V组。
主要安全终点是9个月时无系统相关并发症。使用心力衰竭临床综合评分评估每位患者对CRT的反应，该评分由纽约心脏协会（NYHA）功能分级的变化、患者总体评估评分、HF事件和心血管死亡组成。主要疗效终点是3至9个月期间MPP组与Bi-V组中反应者的比例。
本试验旨在评估通过单根四极左心室导线进行的MPP是否能改善临床反应者和无反应者对CRT的血流动力学和临床反应。
