Registry-Supported Prospective Trials to Support Regulatory Decisions
Mitchell Krucoff, MD, Duke Clinical Research Institute
Daniel Bertges, MD, Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI)
Misti Malone, PhD, U.S. FDA
Melanie Raska, Boston Scientific
The objectives this Phase include deliverables supporting both higher quality evidence accrual and efficiencies reducing redundant work, costs and study timelines supporting “better, faster, cheaper” prospective randomized and single arm trials. The pandemic impact on cardiovascular medical device research further unmasked the need for more resilient prospective clinical trial designs that can enroll patients and execute protocol-driven care with follow up collecting fit-to-purpose outcomes even in the setting of extensive environmental uncertainties.
A series of Think Tanks have focused on professional society cardiovascular device registry support for prospective device trials across the PASSION CV spectrum of PAD intervention, aortic intervention, coronary intervention, heart valves, heart failure and mechanical circulatory support for shock. Professional society device registry-infrastructure provides patient demographics, procedure and device-rich data, and peri-procedural outcomes through established, sustainable site-based workflow providing site-specific quality metrics.
Working groups focus on developing use cases that leverage registry support for PAD interventional devices, aortic endografts, heart valves, and mechanical circulatory support in cardiogenic shock, heart failure and coronary devices. Additionally, this program included working groups looking at novel, contemporary approaches to international regulatory applications of these data sets, single IRB platforms to accelerate site start-up times, and re-usable minimum core data structure implemented into site-based data entry user interfaces, eliminating redundant site-based work.
Peripheral Arterial Disease (PAD)
Aortic Interventions (i.e., EVAR)
Mechanical Circulatory Support (MDS)
Operations & Data Governance
Global Regulatory Acceptance