Global Consortium of Cardiovascular Registries: Transcatheter Valve initiative

全球心血管登记联盟：经导管瓣膜倡议

• 批准号: 8682413
• 负责人: Art Sedrakyan
• 金额: $ 15万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8682413
• 关键词: Global; Consortium; Cardiovascular; Registries; Transcatheter

Abstract The FDA's vision for post-market surveillance of medical devices highlights the importance of national and international registries and registry consortia to provide key evidence for post-market activities. In May 2011 the FDA and the MDEpiNet Science & Infrastructure Center at Weill Cornell Medical College (WCMC) of Cornell University, which the FDA established to support its mission, launched the International Consortium of Orthopedic Registries (ICOR) as a distributed research and surveillance network focusing on safety and effectiveness of orthopedic implants. In May 2013, the FDA and the Center initiated the creation of the International Consortium of Cardiovascular Registries (ICCR) as a pioneering effort focusing on implantable valves and transcatheter valve technology. As surgical treatment options for valve disease are replaced by newer, less invasive procedures such as transcatheter valve replacement, questions about specific device performance, safety, and effectiveness remain unanswered in real-world settings. We propose implementation of International Consortium of Transcatheter Valve Registries (ICTVR) to develop an innovative framework for post-market surveillance of cardiovascular devices. Our proposal establishes a collaborative global network among transcatheter valve registries to conduct analytic projects within this consortium. The governance model and research projects are innovative and we build from the experience gained from ICOR. The registries participating in this network will identify gaps in evidence, harmonize relevant data and create innovative methodologies to analyze data in a distributed way. Weill Cornell Medical College's experience gained over the 15 years, including our designation as Device Center for Education and Research on Therapeutics (CERT) by the Agency for Healthcare Research and Quality (AHRQ) and as the MDEpiNet Science and Infrastructure Center by the FDA, will serve as a robust base upon which we will implement this initiative. In Aim 1 we propose to develop a multi-national distributive TAVR research network, this includes creating a governance structure whose leadership will oversee the creation of new methodological approaches for research and the establishment of public-private partnerships that will address stakeholder's needs and sustainability. In Aim 2 we align TAVR registry rare endpoint and other key variable definitions that support distributive research by reviewing current date fields in registries; then summarizing, defining, and prioritizing data elements in order to reach consensus on those definitions among registry leads around the world. In Aim 3 we will conduct analytic ICTVR projects using distributive research methods through the description of the variation in international practice patterns, the evaluation of the association between specific patient and procedural characteristics and rare procedure-related adverse outcomes, and determine the association between specific device attributes and in-hospital and mid-term outcomes.

摘要 FDA对医疗器械上市后监督的愿景突显了国家和 国际登记处和登记处联合体为上市后活动提供关键证据。2011年5月 FDA和韦尔康奈尔医学院(WCMC)的MDEpiNet科学与基础设施中心 康奈尔大学是FDA为支持其使命而设立的，它发起了 整形外科注册中心(ICOR)作为一个分布式研究和监测网络，专注于安全和 骨科植入物的有效性。2013年5月，FDA和该中心发起了创建 国际心血管登记联合会(ICCR)作为专注于植入性研究的开创性努力 瓣膜和经导管瓣膜技术。随着瓣膜病的外科治疗方案被 较新、侵入性较小的手术，如经导管瓣膜置换术，关于特定设备的问题 在现实世界中，性能、安全性和有效性仍然没有答案。我们建议实施 国际经导管瓣膜注册联合会(ICTVR)制定了一个创新的框架 心血管设备的上市后监测。我们的建议建立了一个协作的全球网络 在经导管瓣膜登记处之间，在该联盟内进行分析项目。治理模式 研究项目是创新的，我们从ICOR获得的经验中建立起来。注册处 参与这一网络将识别证据中的差距，协调相关数据，并创造创新 以分布式方式分析数据的方法。威尔·康奈尔医学院在 15年，包括我们被指定为治疗学教育和研究设备中心(CERT) 医疗研究和质量机构(AHRQ)和MDEpiNet科学和基础设施 由FDA建立的这一中心将成为我们实施这一倡议的坚实基础。在目标1中，我们 建议发展一个跨国家的分布式TAVR研究网络，这包括创建一个治理 其领导将监督新的研究方法的创建和 建立公私伙伴关系，以满足利益攸关方的需求和可持续性。在AIM 2 我们通过以下方式调整TAVR注册表稀有端点和其他支持分布式研究的关键变量定义 检查注册表中的当前日期字段；然后汇总、定义数据元素并确定其优先顺序，以便 在世界各地的登记主管之间就这些定义达成共识。在目标3中，我们将进行分析 通过描述ICTVR项目在国际上的变化，采用分布式研究方法 实践模式，评估特定患者和程序特征之间的联系，以及 罕见的与手术相关的不良结果，并确定特定设备属性之间的关联 以及住院期间和中期结果。