Emphysema
Conditions
Keywords
emphysema, endobronchial valve, treatments, pulmonary rehabilitation, lung volume reduction
Brief summary
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.
Detailed description
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.
Interventions
DEVICEZephyr Valve Procedure
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.
Sponsors
Pulmonx Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects with severe emphysema considered appropriate for the procedure by the physician. * Subjects who signed an Informed Consent Form to allow data collection.
Exclusion criteria
• Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Pneumothorax from Baseline to 45-days post-procedure | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Treated Lobar Volume Reduction (TLVR) after 45-days post-procedure | At baseline and 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. |
| Percent Change in Treated Lobar Volume Reduction (TLVR) after 45-days post-procedure | At baseline and 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. |
| 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 | The mean absolute change in FEV1(L) relative to Baseline at 6-months, 12-months, 24-months and 36-months post procedure |
| 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 | The mean percent change in FEV1(L) relative to Baseline at 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 | At baseline, 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. |
| 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 | Mean percent change in FEV1(% Predicted) relative to Baseline at 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 | Mean absolute change in the 6MWD from Baseline to 6-months and 12-months post-procedure. |
| 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 | Mean percent change in the 6MWD from Baseline to 6-months and 12-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 | 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. |
| 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 | 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. |
| Absolute Change in BODE Index Total Score from baseline to 6-months and 12-months post-procedure | At baseline, 6-months and 12-months | 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. |
| Percent change in BODE Index Total Score from baseline to 6-months and 12-months post-procedure | At baseline, 6-months and 12-months | 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. |
Countries
United States
Contacts
STUDY_DIRECTORChristina Kutzavitch, PhD
Pulmonx Corporation
Outcome results
None listed