PubMed

Bridging Early Feasibility and Pivotal Trials: Insights From Transcatheter Tricuspid Valve Interventions.

PMID: 42624759 · 2026-08-20

M, o, n, i, c, a, , T, o, c, c, h, i, ;, , E, l, e, o, n, o, r, a, , C, a, p, u, z, z, i, ;, , C, a, r, o, l, i, n, a, , M, a, t, s, u, b, a, y, a, s, h, i, ;, , V, a, l, e, r, i, e, , T, s, e, n, g, -, R, o, g, l, e, r, ;, , V, i, v, i, e, n, n, e, , K, a, y, s, e, r, -, S, o, l, t, y, s, ;, , D, a, r, y, a, , G, h, o, l, a, m, i, ;, , M, a, d, e, l, e, i, n, e, , B, l, a, n, k, e, n, s, p, o, o, r, ;, , N, a, z, i, a, , E, j, a, z, ;, , S, i, l, v, i, a, , R, u, g, g, i, e, r, i, ;, , D, a, v, i, d, e, , D, e, c, a, n, d, i, a, ;, , E, r, i, k, , A, l, v, a, r, a, d, o, ;, , B, r, a, n, d, o, n, , W, i, l, l, i, a, m, s, ;, , M, o, h, a, m, m, e, d, , A, d, i, n, a, n, ;, , P, a, o, l, a, , A, n, t, o, n, i, n, i, ;, , G, i, u, d, i, t, t, a, , C, a, l, l, e, a, ;, , H, e, l, e, n, , B, a, n, k, s

学術誌Clinical therapeutics

年2026-08-20

PMID42624759

抄録

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

公式ソース

PubMedで見る →

データはPubMed / NCBIから取得しています。全文および最新情報は必ず公式記録をご確認ください。