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二、埋植式自动心脏起搏转复除颤器本类装置由埋植式自动心脏除颤器(AID,第一代)开始,在近八年间发展为自动心脏转复除颤器(AICD或ICD,第二代)和最近推出的自动心脏起搏转复除颤器(Automatic Implantable Pacer Cardioverter Defibrillator,AIPCD或PCD,第三代)。AIPCD是提供广泛程控可起搏缓慢心律,抗快速心律失常,具复律和除颤功能的装置,埋植后对各种心律失常都可起治疗作用。美国药物和食品管理局要求AIPCD要经过下列步骤才能批准上市:(1)应用于临床前要进行质量和可靠性测验;(2)临床第一阶段,使用于35～50例(其中美国病人至少10例)要有电生理检查资料;(3)临床第二阶段使用于150～200病人,其中至少有100例随访6个月。目前在临
Second, implanted automatic cardiac pacing defibrillator This class of devices from the implantable automatic cardiac defibrillator (AID, the first generation) began in the past eight years, the development of automatic cardiac defibrillator (AICD Or ICD, second generation) and the recently introduced Automatic Implantable Pacer Cardioverter Defibrillator (AIPCD or PCD, third generation). AIPCD is a device that provides a wide range of programmed paced bradycardia, anti-tachyarrhythmia, cardioversion, and defibrillation. It imparts a therapeutic benefit to various arrhythmias after implantation. The AIPCD requires the AIPCD to go through the following steps to approve the listing: (1) it should be used for quality and reliability testing before it is clinically applied; (2) the first phase of the clinical trial is used in 35 to 50 patients (of which at least US patients 10 cases) to have electrophysiological data; (3) The second phase of clinical use in 150 to 200 patients, of which at least 100 cases were followed up for 6 months. At present