Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain.
Campus Clínic, University of Barcelona, Barcelona, Spain.
J Interv Card Electrophysiol. 2023 Jan;66(1):39-47. doi: 10.1007/s10840-022-01392-w. Epub 2022 Oct 13.
Recent studies showed that an early strategy for ventricular tachycardia (VT) ablation resulted in reduction of VT episodes or mortality. Cardiac magnetic resonance (CMR)-derived border zone channel (BZC) mass has proved to be a strong non-invasive predictor of VT in post-myocardial infarction (MI). CMR-guided VT substrate ablation proved to be safe and effective for reducing sudden cardiac death (SCD) and VA occurrence.
PREVENT-VT is a prospective, randomized, multicenter, and controlled trial designed to evaluate the safety and efficacy of prophylactic CMR-guided VT substrate ablation in chronic post-MI patients with CMR-derived arrhythmogenic scar characteristics. Chronic post-MI patients with late gadolinium enhancement (LGE) CMR will be evaluated. CMR images will be post-processed and the BZC mass measured: patients with a BZC mass > 5.15 g will be eligible. Consecutive patients will be enrolled at 3 centers and randomized on a 1:1 basis to undergo a VT substrate ablation (ABLATE arm) or optimal medical treatment (OMT arm). Primary prevention ICD will be implanted following guideline recommendations, while non-ICD candidates will be implanted with an implantable cardiac monitor (ICM). The primary endpoint is a composite outcome of sudden cardiac death (SCD) or sustained monomorphic VT, either treated by an ICD or documented with ICM. Secondary endpoints are procedural safety and efficiency outcomes of CMR-guided ablation.
In some patients, the first VA episode causes SCD or severe neurological damage. The aim of the PREVENT-VT is to evaluate whether primary preventive substrate ablation may be a safe and effective prophylactic therapy for reducing SCD and VA occurrence in patients with previous MI and high-risk scar characteristics based on CMR.
ClinicalTrials.gov, NCT04675073, registered on January 1, 2021.
最近的研究表明，早期策略治疗室性心动过速（VT）可减少 VT 发作或死亡率。心脏磁共振（CMR）衍生的边缘带通道（BZC）质量已被证明是心肌梗死后（MI）VT 的强无创预测因子。CMR 引导的 VT 基质消融已被证明可安全有效地减少心脏性猝死（SCD）和 VA 发生。
PREVENT-VT 是一项前瞻性、随机、多中心、对照试验，旨在评估 CMR 引导的 VT 基质消融在具有 CMR 衍生致心律失常性瘢痕特征的慢性 MI 后患者中的安全性和有效性。将评估患有晚期钆增强（LGE）CMR 的慢性 MI 后患者。CMR 图像将进行后处理，并测量 BZC 质量：BZC 质量＞5.15g 的患者将符合条件。将在 3 个中心连续入组患者，并按 1:1 比例随机分为 VT 基质消融（ABLATE 组）或最佳药物治疗（OMT 组）。根据指南建议植入一级预防 ICD，而非 ICD 候选者则植入植入式心脏监测器（ICM）。主要终点是 SCD 或持续性单形性 VT 的复合结局，由 ICD 治疗或 ICM 记录。次要终点是 CMR 引导消融的程序安全性和效率结局。
在某些患者中，第一次 VA 发作会导致 SCD 或严重的神经损伤。PREVENT-VT 的目的是评估基于 CMR 的高危瘢痕特征的 MI 后患者，预防性基质消融是否可作为安全有效的预防性治疗方法，以降低 SCD 和 VA 发生。
ClinicalTrials.gov，NCT04675073，于 2021 年 1 月 1 日注册。
