Randomized Trial of Nonflouroscopic Technologies in Pediatric SVT Ablation

非透视技术在儿科 SVT 消融中的随机试验

• 批准号: 8486483
• 负责人: Jane W. Newburger
• 金额: $ 52.2万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8486483
• 关键词: Ablation; Acute; Adoption; Adverse event; Affect; Age; Air; Anatomy; Applications Grants; Area; Arrhythmia; Binding; Blood Vessels; Cardiac; Catheterization; Catheters; Characteristics; Charge; Child; Childhood; Clinical; Complex; Cost-Benefit Analysis; Data; Discipline; Dose; Enrollment; Exposure to; Failure; Feasibility Studies; Fluoroscopy; Future; Heart; Heart Diseases; Image; Imaging Techniques; Imaging technology; Incidence; Individual; Inferior; Intention; Intervention; Ionizing radiation; Knowledge; Laboratories; Left; Malignant Neoplasms; Methods; Modeling; Outcome; Pathway interactions; Patients; Population Study; Pre-Excitation Syndromes; Procedures; Prospective Studies; Radiation; Randomized; Recurrence; Resources; Risk; Safety; Sample Size; Serious Adverse Event; Side; Skin; Source; Stratification; Supraventricular tachycardia; Techniques; Technology; Testing; Time; Translations; base; blind; cancer risk; clinical application; experience; follow-up; interest; prevent; primary outcome; prospective; radiation hazard; randomized trial; secondary outcome; success; young adult

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.

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SVT，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术是儿科电生理学家最常进行的手术。荧光透视用于在消融期间引导导管，但构成辐射暴露和伴随癌症风险的重要来源。非透视成像（NFI）技术用于更复杂的消融术，但其用于减少SVT消融术中的透视仅在小型单中心研究中描述。我们提出了一项多中心、前瞻性、单盲、随机非劣效性试验，受试者年龄6 < 21岁，心脏正常，正在接受SVT消融术。患者将被分配到使用荧光透视增强的NFI（“NFI策略”）或标准荧光透视（“标准治疗”）进行消融，随机化按术者（主治电生理学家）和临床SVT机制分层。我们的主要假设是，NFI策略在消融失败方面不劣于标准治疗。将在术前、术中和出院时以及随机化后2个月收集数据。次要结局包括随机分组后2个月和试验结束时SVT复发、不良事件发生率、手术时间和费用、透视时间和辐射剂量。样本量为714例受试者，保守估计必要的入组期为22个月。所有主要分析将在意向治疗基础上进行。对于主要终点，风险差异将估计为NFI策略和标准治疗之间急性消融失败率的差异，并将使用精确二项式方法生成单侧95%置信上限。这项拟议的非劣效性试验可以确定SVT消融的替代成像途径的有效性，同时最大限度地降低电离辐射造成的严重晚期不良后遗症的风险。本研究中获得的知识可以彻底改变所有儿童的消融标准实践，并作为其他介入学科类似研究的范例。 相关性：室上性心动过速（SVT）消融术使健康儿童暴露于辐射，增加了他们患癌症的风险。我们将比较使用非荧光透视成像的消融术与标准荧光透视，以探索是否可以在不改变SVT消融术的有效性或安全性的情况下大幅减少辐射暴露。本研究将作为儿科导管介入技术转化的模型。