FDA Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation -
标准简介
Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation -[附网盘链接]由FDA于之前发布，适用于美国。标准截图
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标准文档说明
标准文档类型为Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation -[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation Guidance for Industry and Food and Drug Administration Staff This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 1. Introduction This guidance provides FDA’s recommendations on clinical trial designs for surgical ablation devices intended for the treatment of atrial fibrillation (AF). The recommendations in this guidance address clinical studies for new surgical ablation devices intended for treatment of AF, as well as for legally marketed surgical ablation devices for which a new indication for treatment of AF is sought. Atrial fibrillation is a complex arrhythmia and its precise mechanisms remain unclear. Current treatments span a spectrum of non-invasive to highly invasive options and include medical and 1
surgical variants. The success of the MAZE procedure and its successors has led to the development of surgical ablation devices designed to mark cardiac tissue in a manner similar to suture lines, thereby disrupting the path of the electrical impulses causing the patient’s AF. FDA believes that several important elements of appropriate clinical study design – such as inclusion and exclusion criteria and assessment of effectiveness – differ for subjects with longstanding persistent AF, persistent AF, and paroxysmal AF (defined in Section 3) as well as for stand-alone versus concomitant procedures. This guidance addresses those differences. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 1
Cox JL, Schuessler RB, d’Agostino Jr HJ et al; The surgical treatment of atrial fibrillation III. Development of a definitive surgical procedure. J Thorac Cardiovasc Surg 1991;101:569-583.
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