Department of Cardiology, Universitair Medisch Centrum Utrecht, Utrecht, The Netherlands
Department of Public Health, Healthcare Innovation & Evaluation and Medical Humanities (PHM), Universitair Medisch Centrum Utrecht, Utrecht, The Netherlands.
BMJ Open. 2021 Oct 25;11(10):e054115. doi: 10.1136/bmjopen-2021-054115.
Achieving optimal placement of the left ventricular (LV) lead in cardiac resynchronisation therapy (CRT) is a prerequisite in order to achieve maximum clinical benefit, and is likely to help avoid non-response. Pacing outside scar tissue and targeting late activated segments may improve outcome. The present study will be the first randomised controlled trial to compare the efficacy of image-guided LV lead delivery to conventional CRT implantation. In addition, to estimate the cost-effectiveness of targeted lead implantation, an early decision analytic model was developed, and described here.
A multicentre, interventional, randomised, controlled trial will be conducted in a total of 130 patients with a class I or IIa indication for CRT implantation. Patients will be stratified to ischaemic heart failure aetiology and 1:1 randomised to either empirical lead placement or live image-guided lead placement. Ultimate lead location and echocardiographic assessment will be performed by core laboratories, blinded to treatment allocation and patient information. Late gadolinium enhancement cardiac magnetic resonance imaging (CMR) and CINE-CMR with feature-tracking postprocessing software will be used to semi-automatically determine myocardial scar and late mechanical activation. The subsequent treatment file with optimal LV-lead positions will be fused with the fluoroscopy, resulting in live target-visualisation during the procedure. The primary endpoint is the difference in percentage of successfully targeted LV-lead location. Secondary endpoints are relative percentage reduction in indexed LV end-systolic volume, a hierarchical clinical endpoint, and quality of life. The early analytic model was developed using a Markov-model, consisting of seven mutually exclusive health states.
The protocol was approved by the Medical Research Ethics Committee Utrecht (NL73416.041.20). All participants are required to provide written informed consent. Results will be submitted to peer-reviewed journals.
NCT05053568; Trial NL8666.
在心脏再同步治疗（CRT）中实现左心室（LV）导线的最佳放置是获得最大临床获益的前提条件，并且可能有助于避免无反应。起搏于瘢痕组织外并针对晚期激活节段可能改善结果。本研究将是首次比较图像引导 LV 导线输送与常规 CRT 植入的疗效的随机对照试验。此外，为了评估靶向导线植入的成本效益，开发了一个早期决策分析模型，并在此进行描述。
将在总共 130 名具有 CRT 植入 I 类或 IIa 类适应证的患者中进行一项多中心、干预性、随机、对照试验。患者将按缺血性心力衰竭病因分层，1:1 随机分为经验性导线放置或实时图像引导的导线放置。核心实验室将对最终导线位置和超声心动图评估进行盲法处理，不了解治疗分配和患者信息。迟钆增强心脏磁共振成像（CMR）和 CINE-CMR 与特征跟踪后处理软件将用于半自动确定心肌瘢痕和晚期机械激活。随后的治疗文件将与最佳 LV 导线位置融合，在手术过程中实现实时目标可视化。主要终点是成功靶向 LV 导线位置的百分比差异。次要终点是索引化 LV 收缩末期容积的相对百分比降低，这是一个分层临床终点，以及生活质量。早期分析模型使用 Markov 模型开发，该模型由七个相互排斥的健康状态组成。
该方案已获得乌得勒支医学研究伦理委员会（NL73416.041.20）的批准。所有参与者都需要提供书面知情同意书。研究结果将提交给同行评议的期刊。
NCT05053568；试验 NL8666。
