Zephyr Valve Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- Incidence Rate of Pneumothorax from Baseline to 45-days post-procedure
研究概览
简要总结
The purpose of this Post-Approval Registry is to gather ongoing safety and effectiveness assessment of the Zephyr Valve treatment in a real-world setting.
详细描述
The Zephyr Valve Registry (ZEVR) is a multi-center, single-arm, prospective Registry. The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of patients with hyperinflation associated with severe emphysema, in regions of the lung that have little to no collateral ventilation.
Approximately 150 patients undergoing Zephyr Valve treatment in the commercial setting will be enrolled and followed out to 3 years. Assessments will be conducted at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure. The Zephyr Valve Registry will be conducted at a minimum of 5, and a maximum of 10 clinical sites.
Subjects prescribed Zephyr Valve treatment for their emphysema will be consented and will be enrolled only after determination of little to no collateral ventilation between target and ipsilateral lobes. Safety and effectiveness of the Zephyr Valve treatment will be evaluated post-treatment based on data collected out to 3 years after the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with severe emphysema considered appropriate for the procedure by the physician.
- •Subjects who signed an Informed Consent Form to allow data collection.
排除标准
- •Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).
结局指标
主要结局
Incidence Rate of Pneumothorax from Baseline to 45-days post-procedure
时间窗: Baseline to 45-days post-procedure
The percentage of study participants undergoing the Zephyr Valve Procedure who develop a pneumothorax from the date of the procedure to 45-day post intervention.
Incidence Rate of Serious Adverse Events (SAEs) of Interest from Baseline to 3 years post-procedure
时间窗: Baseline to 3 years post-procedure
The percentage of study participants who experience a device and/or procedure related SAE including but not limited chronic obstructive pulmonary disease (COPD) exacerbation, hemoptysis, pneumonia, respiratory failure, Valve expectoration and Valve migration
次要结局
- Percent Change in Forced Expiratory Volume in 1 second FEV1 (L) Post Bronchodilator from baseline to 6-months, 12-months, 24-months and 36-months post-procedure(At baseline, 6-months, 12-months, 24-months and 36-months post-procedure)
- Absolute Change in Six-Minute Walk Distance (6MWD) from baseline to 6-months and 12-months post-procedure(At baseline, 6-months and 12-months)
- Absolute Change in Treated Lobar Volume Reduction (TLVR) after 45-days post-procedure(At baseline and after 45-days post-procedure)
- Absolute Change in Forced Expiratory Volume in 1 second FEV1 (L) Post Bronchodilator from baseline to 6-months, 12-months, 24-months and 36-months post-procedure(At baseline, 6-months, 12-months, 24-months and 36-months post-procedure)
- Percent Change in Forced Expiratory Volume in 1 second FEV1 (% Predicted) Post Bronchodilator from baseline to 6-months, 12-months, 24-months and 36-months post-procedure(At baseline, 6-months, 12-months, 24-months and 36-months post-procedure)
- Percent Change in Treated Lobar Volume Reduction (TLVR) after 45-days post-procedure(At baseline and after 45-days post-procedure)
- Absolute Change in Forced Expiratory Volume in 1 second FEV1 (% Predicted) Post Bronchodilator from baseline to 6-months, 12-months, 24-months and 36-months post-procedure(At baseline, 6-months, 12-months, 24-months and 36-months post-procedure)
- Absolute Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from baseline to 6-months and 12-months post-procedure(At baseline, 6-months and 12-months)
- Absolute Change in BODE Index Total Score from baseline to 6-months and 12-months post-procedure(At baseline, 6-months and 12-months)
- Percent Change in Six-Minute Walk Distance (6MWD) from baseline to 6-months and 12-months post-procedure(At baseline, 6-months and 12-months)
- Percent Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from baseline to 6-months and 12-months post-procedure(At baseline, 6-months and 12-months)
- Percent change in BODE Index Total Score from baseline to 6-months and 12-months post-procedure(At baseline, 6-months and 12-months)