Zephyr Valve Registry (ZEVR)

Pulmonx

Status

Active, not recruiting

Conditions

Emphysema

Treatments

Device: Zephyr Valve Procedure

Study type

Observational

Funder types

Industry

Identifiers

NCT04186546

630-0024-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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).