Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study

Absolute Change in Target Lobe Volume for EBV Group (ITT Population)

Target Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume.

Time frame: At baseline and after 3 months

Percent Change in Target Lobe Volume for EBV Group (ITT Population)

Target Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume.

Time frame: At baseline and after 3 months

Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months

The threshold of TLVR ≥350 mL was used to determine the proportion of subjects that achieved this amount of TLVR in the EBV group.

Time frame: At baseline and after 3 months

Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months

The mean absolute change in FEV1(L) relative to Baseline at 3 months between the EBV and SoC groups

Time frame: At baseline and after 3 months

Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months

The mean absolute change in FEV1(% Predicted) relative to Baseline at 3 months between the EBV and SoC groups

Time frame: At baseline and after 3 months

Absolute Change in Residual Volume (RV) at 3 Months

Mean absolute change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups

Time frame: At baseline and after 3 months

Percent Change in Residual Volume (RV) at 3 Months

Mean percent change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups

Time frame: At baseline and after 3 months

Percent Predicted Change in Residual Volume at 3 Months

Percent predicted change in RV relative to Baseline at 3 months between the EBV and SoC groups

Time frame: At baseline and after 3 months

Absolute Change in Six-Minute Walk Distance at 3 Months

Mean absolute change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC

Time frame: At baseline and after 3 months

Percent Change in Six-Minute Walk Distance at 3 Months

Mean percent change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC

Time frame: At baseline and after 3 months

Absolute Change in the SGRQ Total Score From Baseline to 3 Months

Mean absolute change in the St. George's Respiratory Questionnaire Total Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating more limitations.

Time frame: At baseline and after 3 months

Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months

Mean percent change in the SGRQ Total Score from Baseline to 3 months in the EBV group compared to the SoC group

Time frame: At baseline and after 3 months

Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months

Mean absolute change in the Modified Medical Research Council (mMRC) Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.

Time frame: At baseline and after 3 months

Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months

Mean percent change in the mMRC Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.

Time frame: At baseline and after 3 months

Absolute Change in the CAT Total Score From Baseline to 3 Months

Mean absolute change in the COPD Assessment Test (CAT) Total Score from Baseline to 3 months in the EBV group compared to the SoC group. The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease.

Time frame: At baseline and after 3 months

Percent Change (%) in CAT Total Score From Baseline to 3 Months

The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease. Higher scores denote a more severe impact of COPD on a patient's life.

Time frame: At baseline and after 3 months

Absolute Change in EQ-5D Summary Index From Baseline to 3 Months

Mean absolute change in the EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group. EQ-5D is a standardized instrument to measure health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D health states may be converted into a single summary index by applying a formula that attaches weights to each of the levels in each dimension. The maximum score of 1 indicates the best health state, while 0 indicates the worst health state.

Time frame: At baseline and after 3 months

Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months

Mean percent change in EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group.

Time frame: At baseline and after 3 months

Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months

Mean absolute change in the EQ-5D VAS (Health State Today) Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating better outcome.

Time frame: At baseline and after 3 months