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.
We propose the creation of an International Consortium of Transcatheter Valve Registries (ICTVR) as a model initiative to strengthen the emerging partnership of the cardiovascular registries worldwide. The ICTVR is overseen by FDA's MDEpiNet Science and Infrastructure Center at Weill Cornell Medical College in collaboration with US TVT registry. Through this collaborative effort, partners will harmonize data, identify gaps in evidence and create methodologies to analyze data in a distributed way leading to an expanded worldwide post-market surveillance system.
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