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Registry-Supported Prospective Trials to Support Regulatory Decisions

 

 

 

 

 

 

 

 

 

 

 

 

Co-Principal Investigators: 

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 MDEpiNet PASSION program is partnering with the Cardiac Safety Research Consortium and Heart Valve Collaboratory for 2024. Our current spectrum of workstreams, active since March 2024, are focused on facilitating the quality, efficiency and cost of benefit/risk evidence development for class III CV devices in the USA and globally. Topics include: 

  • Global regulatory acceptance for regulatory submissions using real world evidence (RWE)

  • Integration and interoperability of clinical registry data, UDI adoption, and global consensus clinical data standards to support device trial operations

  • Safety endpoint reporting validation from the American Heart Association Cardiogenic Shock registry in patients treated with circulatory support devices

  • Operational advances for prospective randomized cardiogenic shock trials, including:  1) RCTs imbedded into RW infrastructure (AHA Shock Registry), 2) Role of single IRB structure, and 3) Informed consent and exemption from informed consent (EFIC) patient enrollment in shock trials

  • Diversity, Equity & Inclusion Action Plans for CV Device IDE studies: conceptual and biostatistical consensus standards

  • Building evidence to move from biochemical to clinically relevant re-definition of “peri-procedural myocardial infarction” in IDE studies of coronary revascularization devices

  • Conceptual, statistical and operational strategies to support high quality, efficient, lifelong follow up of patients following heart valve implantation

 

Work Groups are co-chaired by clinical, academic, regulatory, industry and professional society registry partners.  All stakeholder groups contribute leadership, resources & subject matter expertise to collaboratively resolve barriers and improve the quality and efficiency of evidence development to enhance the speed and lower the costs of getting newer, safer innovative CV devices to patients faster. 

 

2024 Work Stream Leadership:

  • Long, Long Follow-up (<10yrs/Heart Valves)

    • Sreek Vemulapalli, MD (Duke); Mahesh Madhavan, MD (Cardiac Research Foundation); Changfu Wu, PhD (U.S.FDA); Roseann White (Independent Consultant/Statistician); Michael Bowdish (Society of Thoracic Surgery/TVTR/Cedars-Sinai Medical Center); Erin Spinner (Abbott Vascular); Jaime Wheeler (Edwards)

  • Coronary Artery Disease Use Case

    • Mitchell Krucoff (Duke/DCRI); Don Cutlip MD (Harvard/Baim Institute); Dom Allocco, MD (Shockwave Medical); Lydia Glaw, MD (U.S.FDA); Jeptha Curtis, MD (NCDR Cath PCI/Yale)

  • Health Equity/Diversity, Equity & Inclusion

    • Co-chairs: Wayne Batchelor, MD (Inova); Megan Coylewright, MD (ACC Cardiosmart); Dan Stephens, PhD (BSCI); Brittany Caldwell, PhD (U.S. FDA); Misty Malone (U.S. FDA); Roberta (Bobbi) Chapman (Abiomed J&J Medtech)

  • Registry-supported Trial Operations

    • Ernest Spitzer, MD (Cardialysis), James Tcheng, MD (Duke); Rebecca Torguson (U.S.FDA); David Erlange (Swedeheart/SCAAR)

  • Cardiogenic Shock and MCS

    • David Morrow (Harvard Brigham & Women’s); Pieter Kappetein (Medtronic); Christine Rutan (AHA Shock Registry); Nicole Gillette (U.S. FDA); Mauro Moscucci (U.S. FDA)

Think Tanks

March 9, 2024

December 12, 2024

March 7 & 8, 2025

More information coming soon!

PASSION/RAPID
Phase IV

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