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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ZEVR-Zephyr Valve Registry


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General
Study Status Study Pending
Application Number P180002 S005/ PAS001
Date Current Protocol Accepted  
Study Name ZEVR-Zephyr Valve Registry
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 Design Description Multi-center, single-arm, prospective Registry to be conducted at up to 10 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 Description Adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation
Sample Size 150
Data Collection 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


ZEVR-Zephyr Valve Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/28/2019    
one year report 06/28/2020    
18 month report 12/28/2020    
two year report 06/28/2021    
three year report 06/28/2022    
four year report 06/28/2023    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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