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，SVT 消融是儿科电生理学家最常进行的手术。荧光镜用于在消融过程中引导导管，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手术，但仅在小型单中心研究中描述了它们在 SVT 消融中减少透视的用途。我们建议对年龄 6 < 21 岁、心脏正常、正在接受 SVT 消融的受试者进行一项多中心、前瞻性、单盲、随机非劣效性试验。患者将被分配使用 NFI 增强荧光检查（“NFI 策略”）或标准荧光检查（“标准治疗”）进行消融，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，就消融失败而言，NFI 策略并不逊色于标准疗法。将在手术之前、期间和出院时以及随机分组后两个月收集数据。次要结局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、手术时间和费用、透视时间和辐射剂量。样本量为714名受试者，必要的计提期保守估计为22个月。所有主要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急性消融失败率的差异，并且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能会确定 SVT 消融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严重晚期不良后遗症的风险。这项研究中获得的知识可能会彻底改变所有儿童消融的标准实践，并为其他介入学科的类似研究提供范例。 相关性：室上性心动过速 (SVT) 消融会使其他健康的儿童暴露在辐射下，增加他们患癌症的风险。我们将比较使用非荧光镜成像的消融与标准荧光镜检查，以探讨是否可以在不改变 SVT 消融疗效或安全性的情况下大幅减少辐射暴露。这项研究将作为儿科导管干预技术转化的模型。