Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The rate of effective closure of the ductus arteriosus among subjects with a successful Piccolo implant as assessed by the presence of either a Grade 0 or Grade 1 shunt at the 6-month follow-up by transthoracic echocardiography
研究概览
简要总结
The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect safety and efficacy information for evaluating the results of its clinical use.
详细描述
The Surveillance will be conducted per the standards required by the Ministry of Health, Labour and Welfare (MHLW) and in the standards for post-marketing surveillances and studies [except for those defined in the Ministerial Ordinance on Good Clinical Practice for Medical Devices (MHLW Ordinance No. 36, 2005)] based on Paragraph 4, Article 23-2-9 (including application mutatis mutandis per Article 23-2-19 of Revised PAL) of the Law on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, etc. (Law No. 145, 1960, hereinafter referred to as "Revised PAL") by the Marketing Authorization Holder or accredited foreign manufacturer of a medical device defined in Paragraph 1, Article 23-2-5 of Revised PAL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The device is used to percutaneously close the PDA of a patient who meets all of the following:
- •PDA ≤4 mm in diameter
- •PDA ≥3 mm in length
- •Weight ≥700 g
排除标准
- •Age <3 days
- •Coarctation of the aorta
- •Left pulmonary artery stenosis
- •Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension
- •Thrombus in the implant site, or sign of venous thrombus in a vessel in which the occluder is inserted and delivered
- •Endocarditis, or infection that can cause bacteremia
- •Allergic or potentially allergic to nickel
结局指标
主要结局
The rate of effective closure of the ductus arteriosus among subjects with a successful Piccolo implant as assessed by the presence of either a Grade 0 or Grade 1 shunt at the 6-month follow-up by transthoracic echocardiography
时间窗: At the 6-month follow-up
The rate of major complications through 180 days after an attempted Piccolo device implant
时间窗: Through 180 days after an attempted Piccolo device implant
次要结局
未报告次要终点