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）： 在此提案中统称为SVT的室内心动过速和预先激素综合症会影响许多没有潜在心脏病的儿童和年轻人。相应地，SVT消融是小儿电生理学家执行的最常见过程。透视镜用于在消融过程中引导导管，但构成了辐射暴露和伴随癌症风险的重要来源。非荧光成像（NFI）技术用于更复杂的消融程序，但是它们用于减少SVT消融中的荧光镜检查的用途仅在小型单中心研究中得到了描述。我们提出了一项多中心，前瞻性，单盲，随机的非效率试验，年龄在6岁<21岁的受试者中，正常心脏正在接受SVT消融。将使用荧光镜检查（“ NFI策略”）或标准荧光镜检查（“标准治疗”）的NFI分配患者，并由操作员（主治电生理学家）和临床SVT机制进行随机分析。我们的主要假设是，NFI策略在消融失败方面并不比标准疗法较低。数据将在过程中，期间和出院之前以及随机分组后两个月收集。次要结果包括在随机分组后两个月和试验结束后的SVT复发，不良事件，程序时间和电荷的发生，荧光镜检查时间和辐射剂量。样本量为714名受试者，必要的应计时期估计为22个月。所有主要分析将以意向性治疗进行。对于主要终点，将估计风险差异是NFI策略和标准治疗之间急性消融失败率的差异，并且将使用精确的二项式方法产生单方面的95％置信度。这项提出的非效率试验可能会确定SVT消融的替代成像途径的功效，同时最大程度地减少了因电离辐射而发生严重的晚期不良后遗症的风险。在这项研究中获得的知识可以彻底改变所有儿童消融的标准实践，并作为其他介入学科类似研究的范式。 相关性：上室心动过速（SVT）的消融使其他健康的儿童暴露于辐射中，增加了癌症的风险。我们将使用非荧光成像与标准荧光镜检查进行消融，以探索在不改变SVT消融功效或安全性的情况下可以大大减少辐射暴露。这项研究将作为基于小儿导管干预的技术翻译模型。