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: 8915909
• 负责人: Art Sedrakyan
• 金额: $ 3.75万
• 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 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8915909
• 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.

抽象的 FDA 对医疗器械上市后监管的愿景强调了国家和地区监管的重要性 国际注册管理机构和注册管理机构联盟为上市后活动提供关键证据。 2011年5月 FDA 和威尔康奈尔医学院 (WCMC) 的 MDEpiNet 科学与基础设施中心 FDA 为支持其使命而建立的康奈尔大学发起了国际联盟 骨科注册中心 (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和该中心发起创建 国际心血管登记协会 (ICCR) 是专注于植入式医疗器械的开创性努力 瓣膜和经导管瓣膜技术。随着瓣膜疾病的手术治疗方案被 更新的、侵入性较小的手术，例如经导管瓣膜置换术、有关特定设备的问题 在现实环境中，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盟 (ICTVR) 旨在开发一个创新框架 心血管器械的上市后监测。我们的建议建立一个全球协作网络 经导管瓣膜注册中心在该联盟内开展分析项目。治理模式 我们的研究项目具有创新性，我们借鉴了 ICOR 的经验。登记处 参与该网络将查明证据差距、协调相关数据并创造创新 以分布式方式分析数据的方法。威尔康奈尔医学院的经验 15 年，包括我们被指定为治疗学教育和研究设备中心 (CERT) 医疗保健研究和质量局 (AHRQ) 以及 MDEpiNet 科学和基础设施 FDA 设立的中心将成为我们实施这一举措的坚实基础。在目标 1 中，我们 提议开发一个跨国分布式 TAVR 研究网络，其中包括建立一个治理机制 其领导层将监督新的研究方法的创建和 建立公私伙伴关系，以满足利益相关者的需求和可持续性。目标 2 我们通过 TAVR 注册稀有终点和其他支持分布式研究的关键变量定义进行调整 检查注册表中的当前日期字段；然后总结、定义数据元素并确定其优先级，以便 世界各地的注册管理机构负责人就这些定义达成共识。在目标 3 中，我们将进行分析 ICTVR 项目使用分布式研究方法，通过描述国际变化 实践模式、特定患者和程序特征之间关联的评估以及 罕见的手术相关不良结果，并确定特定设备属性之间的关联 以及院内和中期结果。

项目成果

An International Vascular Registry Infrastructure for Medical Device Evaluation and Surveillance.

用于医疗器械评估和监测的国际血管登记基础设施。

• DOI: 10.1016/j.ejvs.2017.01.002
• 发表时间: 2017
• 期刊: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
• 作者: Sedrakyan,A;Cronenwett,JL;Venermo,M;Kraiss,L;Marinac-Dabic,D;Björck,M
• 通讯作者: Björck,M