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. The implementation of International Consortium of Transcatheter Valve Registries (ICTVR) means development of an innovative framework for post-market surveillance of cardiovascular devices. This initiative establishes a collaborative global network among transcatheter valve registries to conduct analytic projects within the consortium. The governance model and research projects are innovative and we have built from the experience gained from the International Consortium of Orthopedic Registries. 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.
ICTVR has several aims:
Develop a multi-national distributive transcatheter aortic valve replacement (TAVR) research network, including 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.
Align TAVR registry rare endpoints 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.
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.