Randomized Trial of Nonflouroscopic Technologies in Pediatric SVT Ablation

描述(由申请人提供)： 室上性心动过速和预激综合征，在本提案中统称为室上性心动过速，影响许多没有潜在心脏病的儿童和年轻人。相应地，室上性心动过速消融是儿科电生理学家最常进行的手术。在消融过程中，荧光透视被用来引导导管，但它构成了辐射暴露和伴随的癌症风险的重要来源。非透视成像(NFI)技术被用于更复杂的消融程序，但它们在SVT消融中减少荧光透视的应用仅在小型、单中心研究中被描述。我们提出了一项多中心、前瞻性、单盲、随机的非劣势试验，受试者年龄为6&21岁，心脏正常，正在接受室上性心动过速消融。患者将被分配到使用加透视的NFI消融(“NFI策略”)或标准透视(“标准治疗”)，并按操作员(主治电生理学家)和临床SVT机制进行随机分层。我们的主要假设是，在消融失败方面，NFI策略并不逊色于标准治疗。数据将在随机化之前、过程中和出院时以及随机化后两个月收集。次要结果包括随机分组后两个月和试验结束时的SVT复发、不良事件的发生、手术次数和费用、透视时间和辐射剂量。样本大小为714名受试者，保守估计必要的累计期为22个月。所有初步分析都将在意向治疗的基础上进行。对于主要终点，风险差异将被估计为NFI策略和标准治疗之间的急性消融失败率的差异，并且将使用精确的二项式方法产生单边的95%的上置信限。这项拟议的非劣效性试验可能会确定另一种用于SVT消融的成像途径的有效性，同时将电离辐射造成的严重晚期不良后遗症的风险降至最低。这项研究所获得的知识可能会对所有儿童的消融标准实践产生革命性的影响，并为其他干预学科的类似研究提供范例。 相关性：消融室上性心动过速(SVT)会使原本健康的儿童暴露在辐射下，增加他们患癌症的风险。我们将比较使用非透视成像的消融和标准透视，以探索是否可以在不改变SVT消融的有效性或安全性的情况下大幅减少辐射暴露。这项研究将作为儿童导管介入技术转化的典范。

DESCRIPTION (provided by applicant): Supraventricular tachycardia and preexcitation syndromes, collectively referred to as SVT in this proposal, affect many children and young adults without underlying heart disease. Correspondingly, SVT ablation is the most frequent procedure performed by pediatric electrophysiologists. Fluoroscopy is used to guide catheters during ablation, but constitutes a significant source of radiation exposure and concomitant cancer risk. Nonfluoroscopic imaging (NFI) techniques are used for more complex ablation procedures, but their use to reduce fluoroscopy in SVT ablation has only been described in small, single-center studies. We propose a multi-center, prospective, single-blind, randomized non-inferiority trial in subjects ages 6 < 21 years with normal hearts who are undergoing SVT ablation. Patients will be assigned to ablation using NFI augmented with fluoroscopy ("NFI strategy") or standard fluoroscopy ("standard therapy"), with randomization stratified by operator (attending electrophysiologist) and clinical SVT mechanism. Our primary hypothesis is that the NFI strategy is not inferior to standard therapy with respect to ablation failure. Data will be collected prior to, during and at discharge from the procedure, and at two months post randomization. Secondary outcomes include SVT recurrence two months after randomization and at trial end, the occurrence of adverse events, procedure times and charges, fluoroscopy time and radiation dose. The sample size is 714 subjects, and the necessary accrual period is conservatively estimated to be 22 months. All primary analyses will be performed on an intention-to-treat basis. For the primary endpoint, the risk difference will be estimated as the difference in the acute ablation failure rate between the NFI strategy and standard therapy, and a one-sided upper 95% confidence bound will be generated using the exact binomial method. This proposed non-inferiority trial may establish the efficacy of an alternative imaging pathway for SVT ablation, while minimizing the risk of severe late adverse sequelae from ionizing radiation. The knowledge gained in this study could revolutionize standard practice of ablation in all children, and serve as a paradigm for similar studies in other interventional disciplines. RELEVANCE: Ablation of supraventricular tachycardia (SVT) exposes otherwise healthy children to radiation, increasing their risk of cancer. We will compare ablation using non-fluoroscopic imaging to standard fluoroscopy, to explore whether radiation exposure can be substantially reduced without changing efficacy or safety of SVT ablation. This study will serve as a model for technology translation in pediatric catheter-based intervention.