title: FDA perspective on clinical trial design for cardiovascular devices.
authors.forename: Eric
authors.initials: E
authors.lastname: Chen
authors.forename: Wolf
authors.initials: W
authors.lastname: Sapirstein
authors.forename: Chul
authors.initials: C
authors.lastname: Ahn
authors.forename: Julie
authors.initials: J
authors.lastname: Swain
authors.forename: Bram
authors.initials: B
authors.lastname: Zuckerman
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data; D018795:Device Approval / Q000592:standards*; D004867:Equipment Design; D006350:Heart Valve Prosthesis; D006353:Heart-Assist Devices; D006801:Humans; D007373:Interinstitutional Relations; D007391:International Cooperation; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D012107:Research Design; D012306:Risk; D018401:Sample Size; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*