The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 29
- 主要终点
- Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure
研究概览
简要总结
This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.
详细描述
This post-market study is a single-arm, prospective, multi-center Registry. It is designed to assess 36-month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of Spiration Valve System therapy for the treatment of severe emphysema in the United States.
Subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
- •Subjects must understand and voluntarily sign an informed consent form.
排除标准
- •Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
- •Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
- •Subjects who have incomplete screening or baseline data.
结局指标
主要结局
Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure
时间窗: 12 months
The primary safety endpoint will be the incidence of device-related and procedure-related pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure.
Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure
时间窗: 36 months
An additional analysis will present the rate (per patient-year) of TAEsSI.
次要结局
- 45-day pneumothorax rate(45 days)
- Survival rate over 24 months(24 months)