|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P180002 S005/ PAS001 |
| Date Original Protocol Accepted |
10/02/2019
|
| Date Current Protocol Accepted |
03/25/2023
|
| Study Name |
ZEVR-Zephyr Valve Registry
|
| Device Name |
Zephyr Endobronchial Valve (EBV) System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective Cohort Study: Multi-center, single-arm, prospective Registry to be conducted at up to 15 clinical sites. Approximately 150 patients with severe emphysema undergoing Zephyr Valve treatment will be enrolled and followed out to 3 years. Assessments will be performed 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. Enrollment is anticipated to be completed over 24 months. A minimum of 20 subjects treated with at least one Zephyr 5.5-LP EBV will be enrolled.
|
| Study Population |
Adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. Concurrent control comparison group.
|
| Sample Size |
150
|
| Key Study Endpoints |
Safety endpoints:
Incidence rate of Pneumothorax at 45-days post-procedure.
Incidence rate of device/procedure related Serious Adverse Events (SAE) including but not limited to COPD exacerbations, pneumonia, hemoptysis, valve expectoration, valve migration and respiratory failure.
Effectiveness endpoints:
Treated Lobar Volume Reduction (TLVR) assessed by HRCT at 45-days.
Forced Expiratory Volume in 1 second (FEV1) at 6-months, 12-months, 24-months and 36-months.
6MWD at 6-months and 12-months.
SGRQ at 6-months and 12-months.
BODE Index at 6-months and 12-months.
Percent of patients with a TLVR of =350mL10,11.
Percent of patients with a TLVR of =563mL12.
Responder rates reported as percent of patients meeting the Minimal Clinically Important Difference (MCID) for each variable at 6-months and 12-months.
- MCID for FEV1: Increase of 10% (Liters)
- MCID for 6MWD: Increase of +25 meters
- MCID for SGRQ: Decrease of 4 points
|
| Follow-up Visits and Length of Follow-up |
36 months
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
The most frequently occurring device related SAE is pneumothorax in 28% of enrolled subjects.
The most frequently occurring procedure related SAE is also pneumothorax in 28% of subjects.
In addition to Pneumothorax (45.1%), the most frequently occurring respiratory related AEs at Year 1 is COPD Exacerbation (39.2%), Pneumonia (11.8%), and Respiratory Failure (8.8%).
The most frequently occurring respiratory SAE at Year 1 is also pneumothorax in 44.1% of subjects, followed by COPD Exacerbation (10.8%).
Effectiveness Results
As of June 1, 2023, 106 subjects have completed their 45-day post procedure follow-up visits, 86 subjects have completed their 6-
month follow-up visit, and 63 subjects have completed their 1-year follow-up visit. Effectiveness data available currently is insufficient
for analysis or to make any inferences.
|
| Actual Number of Patients Enrolled |
130
|
| Actual Number of Sites Enrolled |
9
|
| Patient Follow-up Rate |
73.8%
|
