Randomized Clinical Trials for Pediatric Heart Disease

描述(由申请人提供) 南卡罗来纳州的儿童？S心脏计划是一个全州范围的财团 儿科心脏病医生，他们照顾了全美370万居民中的90% 州政府。这个联合体拥有成为世界上一个中心的所有关键要素。 建议的研究网络：足够的患者数量，临床研究 基础设施、科目注册的跟踪记录以及演示 致力于假说驱动的临床研究。申请中心，MUSC， S心脏计划是儿童第三转诊中心吗？当前MUSC 教职员工以S的身份参与了20项多中心临床试验 或登记处(10个开放，2个在IRB审查中)。此应用程序的PI具有 我是20个国家中的4个的首席调查员。这些协议范围 从行业赞助的药物或设备试验，到NIH赞助的药物试验 对于胎儿心脏传导阻滞，向美国国立卫生研究院的预期登记。教职员工也 目前运行11个本地临床研究方案。参与所有 这些方案得到了专门的儿科心脏研究支持 由2名全职RN协调员和1名额外的RN FTE组成的小组。合并后的 大量的资源和强大的研究基础设施使 南加州大学的S将成为18家招聘机构中排名前2位的招聘人员 已完成或正在进行的多中心研究。按照要求，该提案包含 一项短期和长期的协议。 短期的。体肺侧支循环线圈闭塞的随机试验 在方坦之前。多因素影响单纯性糖尿病患者的发病率和死亡率 接受Fontan手术的脑室病人。最近考虑的一个是 是否存在APC？S。然而，多项回顾性研究均未能 明确界定APC的作用？S或他们的最佳管理。该协议 是否前瞻性评价APC？S在术后方坦中的作用 血流动力学和并发症，并决定了术前弹簧圈的重要性 在他们的管理中进行栓塞术。 长期的。胺碘酮与冷冻头导管消融的随机对照试验 治疗复发性房内折返性心动过速(IART) 患有先天性心脏病。IART，发病率最大的单一原因 先天性心脏病修复期过晚，往往危及生命， 治疗起来令人沮丧，而且没有明显优越的治疗方法。该协议将 前瞻性比较最成功的药物治疗和导管治疗 艺术。在至少2年的随访中，主要终点将是IART 消融成功后或药物负荷和复律后复发。

DESCRIPTION (provided by the applicant) The Children?s Heart Program of South Carolina is a statewide consortium of pediatric cardiologists, who care for 90% of the 3.7 million residents in the state. This consortium has all the critical elements for a center in the proposed research network: adequate patient volume, clinical research infrastructure, a track record of subject enrollment, and a demonstrated dedication to hypothesis driven clinical research. The applicant center, MUSC, is the tertiary referral center for the Children?s Heart Program. Current MUSC faculty have participated as PI?s in a total of 20 multicenter clinical trials or registries (10 open, 2 under IRB review). The PI of this application has been the lead investigator nationally in 4 of the 20. These protocols range from industry sponsored drug or device trials, to an NIH sponsored drug trial for fetal heart block, to an NIH prospective registry. The faculty also currently runs 11 local clinical research protocols. Participation in all of these protocols is supported by a dedicated pediatric cardiac research support group with 2 full time RN coordinators and an additional RN FTE. The combined resources of high volume and strong research infrastructure have enabled the PI?s at MUSC to be one of the top 2 subject recruiters in 6 of the 18 completed or active multicenter studies. As requested, the proposal contains a short-term and a long-term protocol. Short-Term. Randomized Trial of Aortopulmonary Collateral Coil Occlusion Prior to Fontan. Multiple factors influence morbidity and mortality for single ventricle patients undergoing Fontan operation. One considered recently is the presence of APC?s. However, multiple retrospective studies have failed to clearly delineate the role of APC?s or their optimum management. This protocol will prospectively evaluate the role of APC?s in postoperative Fontan hemodynamics and morbidity, and determine the importance of preoperative coil embolization in their management. Long-Term. Randomized Trial of Amiodarone vs Cooled- Tip Catheter Ablation for Treatment of Recurrent Intra-atrial Reentry Tachycardia (IART) in Patients with Congenital Heart Disease. IART, the single largest cause of morbidity late after repair of congenital heart disease, is often life-threatening, frustrating to treat and has no clearly superior therapy. This protocol will prospectively compare the most successful medical and catheter therapies for IART. The primary endpoint during a minimum of 2 years follow-up will be IART recurrence after successful ablation, or after drug loading and cardioversion.