Long Term Follow up Investigation of Endobronchial Valves in Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 628
- 试验地点
- 1
- 主要终点
- FEV1
研究概览
简要总结
This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.
详细描述
Primary objective is pulmonary function as assessed by FEV1 and secondary objectives are health related quality of life as assessed by the modified MRC dyspnea score and by the COPD assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in Germany. Patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. The study will observe normal clinical practice. No investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. Patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. Zephyr Endobronchial Valve has CE mark and is fully reimbursed in Germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice.
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
- •Patients of both genders of at least 18 years of age
- •Understand and voluntarily sign an informed consent form.
- •FEV1 > 15% predicted and < 45% predicted
- •RV >180% predicted
- •Diagnosis of emphysema with CT evidence of hyperinflation . Absence of collateral ventilation according to Chartis Assessment System
排除标准
- •Active pulmonary infection
结局指标
主要结局
FEV1
时间窗: 2 years
Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)
次要结局
- Modified Medical Research Council (mMRC) Questionnaire(5 years)
- Survival over 5 years(5 years)
- COPD Assessment Test (CAT)(5 years)
