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.
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.
Study Type
OBSERVATIONAL
Enrollment
150
The Pulmonx Zephyr Endobronchial Valve is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The Zephyr Valves are placed in the diseased region of the lung using bronchoscopy. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Chicago
Chicago, Illinois, United States
Northwestern Medicine
Winfield, Illinois, United States
Incidence Rate of Pneumothorax from 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.
Time frame: Baseline to 45-days post-procedure
Incidence Rate of Serious Adverse Events (SAEs) of Interest from 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
Time frame: Baseline to 3 years post-procedure
Absolute Change in Treated Lobar Volume Reduction (TLVR) after 45-days post-procedure
The Treated Lobe Volume Reduction (TLVR) will be evaluated by quantitative analysis of high-resolution computed tomography (HRCT) scans at Baseline and at 45-days post-valve placement to measure the treated lobe volume reduction.
Time frame: At baseline and after 45-days post-procedure
Percent Change in Treated Lobar Volume Reduction (TLVR) after 45-days post-procedure
The Treated Lobe Volume Reduction (TLVR) will be evaluated by quantitative analysis of HRCT scans at Baseline and at 45-days post-valve placement to measure the treated lobe volume reduction.
Time frame: 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
The mean absolute change in FEV1(L) relative to Baseline at 6-months, 12-months, 24-months and 36-months post procedure
Time frame: At baseline, 6-months, 12-months, 24-months and 36-months post-procedure
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Henry Ford Hospital
Detroit, Michigan, United States
The Lung Center
DuBois, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Houston Methodist
Houston, Texas, United States
Inova Health
Fairfax, Virginia, United States
...and 1 more locations
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
The mean percent change in FEV1(L) relative to Baseline at 6-months, 12-months, 24-months and 36-months post procedure
Time frame: At baseline, 6-months, 12-months, 24-months and 36-months 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
The mean absolute change in FEV1(% Predicted) relative to Baseline at 6-months, 12-months, 24-months and 36-months post procedure.
Time frame: 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
Mean percent change in FEV1(% Predicted) relative to Baseline at 6-months, 12-months, 24-months and 36-months post-procedure
Time frame: 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
Mean absolute change in the 6MWD from Baseline to 6-months and 12-months post-procedure.
Time frame: 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
Mean percent change in the 6MWD from Baseline to 6-months and 12-months post-procedure.
Time frame: At baseline, 6-months and 12-months
Absolute Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from baseline to 6-months and 12-months post-procedure
Mean absolute change in the St. George's Respiratory Questionnaire Total Score from Baseline to 6-months and 12-months post-procedure. Scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: 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
Mean percent change in the St. George's Respiratory Questionnaire Total Score from Baseline to 6-months and 12-months post-procedure. Scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: At baseline, 6-months and 12-months
Absolute Change in BODE Index Total Score from baseline to 6-months and 12-months post-procedure
BODE stands for Body mass index, airflow Obstruction, Dyspnea and Exercise capacity. The BODE Index is a tool used to predict the death risk by using an algorithm that considers the following variables: body mass index (BMI, B), airflow obstruction (O) as measured by the post-bronchodilator FEV1 (percentage of predicted value), dyspnea (D) assessed by the modified Medical Research Council (MMRC) score, and exercise tolerance (E) measured by 6 minute walking distance. These variables are graded 0 to 3 (0 or 1 for BMI) and summed to give a total score between 0 and 10. The resulting score is called the BODE index, with higher scores indicating a greater risk of death. The mean absolute change in the BODE score will be calculated from baseline scores compared to the BODE score at 6 months and 12 months post procedure.
Time frame: At baseline, 6-months and 12-months
Percent change in BODE Index Total Score from baseline to 6-months and 12-months post-procedure
BODE stands for Body mass index, airflow Obstruction, Dyspnea and Exercise capacity. The BODE Index is a tool used to predict the death risk by using an algorithm that considers the following variables: body mass index (BMI, B), airflow obstruction (O) as measured by the post-bronchodilator FEV1 (percentage of predicted value), dyspnea (D) assessed by the modified Medical Research Council (MMRC) score, and exercise tolerance (E) measured by 6 minute walking distance. These variables are graded 0 to 3 (0 or 1 for BMI) and summed to give a total score between 0 and 10. The resulting score is called the BODE index, with higher scores indicating a greater risk of death. The mean percent change in the BODE score will be calculated from baseline scores compared to the BODE score at 6 months and 12 months post procedure.
Time frame: At baseline, 6-months and 12-months