Di Biase Luigi, Tung Roderick, Szili-Torok Tamás, Burkhardt J David, Weiss Peter, Tavernier Rene, Berman Adam E, Wissner Erik, Spear William, Chen Xu, Neužil Petr, Skoda Jan, Lakkireddy Dhanunjaya, Schwagten Bruno, Lock Ken, Natale Andrea
Texas Cardiac Arrhythmia Institute at St. David's Medical Center, 3000 N. I-35, Suite 720, Austin, TX, 78705, USA.
Albert Einstein College of Medicine, at Montefiore Hospital, New York, NY, USA.
J Interv Card Electrophysiol. 2017 Apr;48(3):237-245. doi: 10.1007/s10840-016-0217-3. Epub 2017 Jan 7.
Patients with ischemic cardiomyopathy (ICM) are prone to scar-related ventricular tachycardia (VT). The success of VT ablation depends on accurate arrhythmogenic substrate localization, followed by optimal delivery of energy provided by constant electrode-tissue contact. Current manual and remote magnetic navigation (RMN)-guided ablation strategies aim to identify a reentry circuit and to target a critical isthmus through activation and entrainment mapping during ongoing tachycardia. The MAGNETIC VT trial will assess if VT ablation using the Niobe™ ES magnetic navigation system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT and low ejection fraction.
This is a randomized, single-blind, prospective, multicenter post-market study. A total of 386 subjects (193 per group) will be enrolled and randomized 1:1 between treatment with the Niobe ES system and treatment via a manual procedure at up to 20 sites. The study population will consist of patients with ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of ≤35% and implantable cardioverter defibrillator (ICD) who have sustained monomorphic VT. The primary study endpoint is freedom from any recurrence of VT through 12 months. The secondary endpoints are acute success; freedom from any VT at 1 year in a large-scar subpopulation; procedure-related major adverse events; and mortality rate through 12-month follow-up. Follow-up will consist of visits at 3, 6, 9, and 12 months, all of which will include ICD interrogation.
The MAGNETIC VT trial will help determine whether substrate-based ablation of VT with RMN has clinical advantages over manual catheter manipulation.
Clinicaltrials.gov identifier: NCT02637947.
缺血性心肌病（ICM）患者易发生与瘢痕相关的室性心动过速（VT）。VT消融的成功取决于准确的致心律失常基质定位，随后通过恒定的电极-组织接触实现能量的最佳传递。当前的手动和远程磁导航（RMN）引导的消融策略旨在通过在持续性心动过速期间进行激动标测和拖带标测来识别折返环路并靶向关键峡部。MAGNETIC VT试验将评估在患有缺血性瘢痕VT且射血分数低的受试者中，使用Niobe™ ES磁导航系统进行VT消融是否比手动方法产生更好的结果。
这是一项随机、单盲、前瞻性、多中心上市后研究。总共将招募386名受试者（每组193名），并在多达20个地点以1:1的比例随机分为接受Niobe ES系统治疗和通过手动操作治疗两组。研究人群将包括左心室射血分数（LVEF）≤35%且植入式心律转复除颤器（ICD）的缺血性心肌病患者，这些患者发生过持续性单形性VT。主要研究终点是12个月内无VT复发。次要终点包括急性成功；在大瘢痕亚组中1年内无任何VT；与手术相关的主要不良事件；以及12个月随访期间的死亡率。随访将包括在3、6、9和12个月时的就诊，所有这些就诊都将包括ICD问询。
MAGNETIC VT试验将有助于确定基于基质的RMN VT消融是否比手动导管操作具有临床优势。
Clinicaltrials.gov标识符：NCT02637947。
