Bridging Early Feasibility and Pivotal Trials: Insights From Transcatheter Tricuspid Valve Interventions.
PMID: 42624759 ·
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
광고
초록
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
광고
공식 출처
PubMed에서 보기 →데이터는 PubMed / NCBI에서 제공됩니다. 전문과 최신 정보는 반드시 공식 기록을 확인하세요.