Cardiac Arrhythmia Service, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH.
Am Heart J. 2019 Nov;217:13-22. doi: 10.1016/j.ahj.2019.04.002. Epub 2019 Apr 9.
Cardiac resynchronization therapy (CRT) improves outcomes, functional capacity and quality of life in patients with heart failure. Despite two decades of experience with CRT, the rate of non-response remains approximately 30%. CRT efficacy is impacted by pacing location, which is anatomically limited in conventional systems. A new wireless endocardial left ventricular (LV) pacing system allows CRT without such limitations and has shown promise in open-label studies. The purpose of this study is to evaluate its use in a patient population with poor therapeutic alternatives.
The SOLVE CRT study is an international, multi-center, randomized, double-blind, sham-controlled trial of patients with Class I and IIa indications for CRT who have either failed to respond to or have been unable to receive conventional CRT. Enrollment will comprise 350 patients implanted with the wireless CRT system randomized 1:1 to therapy on (Treatment) or therapy off (Control) for the six-month period over which trial primary endpoints will be evaluated. The primary safety endpoint will measure the proportion of patients free from system- and procedure-related complications. Primary efficacy endpoints will assess absolute change in LV end-systolic volume LVESV, proportion of patients reducing LVESV by ≥15% and clinical composite score for Treatment versus Control patients. Primary endpoints will be evaluated on an intention-to-treat basis, though per-protocol and as-treated analysis will also be performed.
SOLVE-CRT will quantify the safety and effectiveness of wireless CRT in non-responders to conventional CRT and indicated patients who have been unable to receive CRT via the usual transvenous approach.
心脏再同步治疗（CRT）可改善心力衰竭患者的预后、功能能力和生活质量。尽管 CRT 已有二十年的应用经验，但无应答率仍约为 30%。CRT 的疗效受起搏部位的影响，而传统系统在解剖学上存在限制。一种新的无线心内膜左心室（LV）起搏系统可实现无限制的 CRT，且在开放标签研究中显示出良好的效果。本研究旨在评估其在治疗选择较差的患者人群中的应用。
SOLVE CRT 研究是一项国际性、多中心、随机、双盲、假对照试验，纳入了 I 类和 IIa 类 CRT 适应证但对常规 CRT 无反应或无法接受常规 CRT 的患者。将招募 350 名患者，植入无线 CRT 系统，随机分为治疗组（Treatment）或对照组（Control），治疗组在六个月内接受治疗，对照组不接受治疗，在此期间将评估试验的主要终点。主要安全性终点将测量无系统和手术相关并发症的患者比例。主要疗效终点将评估 LV 收缩末期容积（LVESV）的绝对变化、LVESV 减少≥15%的患者比例以及治疗组和对照组患者的临床综合评分。主要终点将基于意向治疗进行评估，但也将进行方案和实际治疗分析。
SOLVE-CRT 将定量评估无线 CRT 在常规 CRT 无反应和无法通过常规经静脉途径接受 CRT 的患者中的安全性和有效性。
