Bridging Early Feasibility and Pivotal Trials: Insights From Transcatheter Tricuspid Valve Interventions.
PMID: 42624759 ·
Monica Tocchi, Eleonora Capuzzi, Carolina Matsubayashi, Valerie Tseng-Rogler, Vivienne Kayser-Soltys, Darya Gholami, Madeleine Blankenspoor, Nazia Ejaz, Silvia Ruggieri, Davide Decandia, Erik Alvarado, Brandon Williams, Mohammed Adinan, Paola Antonini, Giuditta Callea, Helen Banks
Abstract
Early feasibility studies (EFS) are critical in the clinical development of high-risk cardiovascular devices, enabling first-in-human evaluation and iterative refinement prior to pivotal investigation. Regulatory frameworks supporting EFS have evolved substantially in the United States (US), while structured European pathways are emerging. This narrative review evaluates the evolution of the US EFS framework and examines its alignment with emerging European initiatives, using transcatheter tricu
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