Zephyr Valve Registry (ZEVR)

NCT04186546 | Active Not Recruiting FDA Device

• 1 other identifier: 630-0024-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 11

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.

Conditions

Emphysema

Keywords

emphysema; endobronchial valve; treatments; pulmonary rehabilitation; lung volume reduction

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Baseline to 3 years post-procedure

Secondary Outcomes (12)

• Absolute Change in Treated Lobar Volume Reduction (TLVR) after 45-days post-procedure

  At baseline and after 45-days post-procedure

• Percent Change in Treated Lobar Volume Reduction (TLVR) after 45-days post-procedure

  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

  At baseline, 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

• 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

Study Arms (1)

Cases

Zephyr Valve Procedure

Device: Zephyr Valve Procedure

Interventions

Zephyr Valve Procedure DEVICE

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.

Also known as: Zephyr Endobronchial Valve, Endobronchial Valve, Bronchoscopic Lung Volume Reduction, BLVR

Cases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Registry population will be comprised of subjects with hyperinflation of the lungs due to severe emphysema that are prescribed the Zephyr Valve treatment by their physician and confirmed to have little to no collateral ventilation.

You may qualify if:

• Subjects with severe emphysema considered appropriate for the procedure by the physician.
• Subjects who signed an Informed Consent Form to allow data collection.

You may not qualify if:

• Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).

Sponsors & Collaborators

• Pulmonx Corporation: lead

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Northwestern Medicine

Winfield, Illinois, 60190, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

The Lung Center

DuBois, Pennsylvania, 15801, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15123, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Inova Health

Fairfax, Virginia, 22031, United States

Location

Froedtert Memorial-Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (11)

• Valipour A, Slebos DJ, Herth F, Darwiche K, Wagner M, Ficker JH, Petermann C, Hubner RH, Stanzel F, Eberhardt R; IMPACT Study Team. Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study. Am J Respir Crit Care Med. 2016 Nov 1;194(9):1073-1082. doi: 10.1164/rccm.201607-1383OC.

  PMID: 27580428 BACKGROUND

• Klooster K, ten Hacken NH, Hartman JE, Kerstjens HA, van Rikxoort EM, Slebos DJ. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med. 2015 Dec 10;373(24):2325-35. doi: 10.1056/NEJMoa1507807.

  PMID: 26650153 BACKGROUND

• Klooster K, Hartman JE, Ten Hacken NH, Slebos DJ. One-Year Follow-Up after Endobronchial Valve Treatment in Patients with Emphysema without Collateral Ventilation Treated in the STELVIO Trial. Respiration. 2017;93(2):112-121. doi: 10.1159/000453529. Epub 2016 Dec 15.

  PMID: 27974713 BACKGROUND

• Hartman JE, Klooster K, Slebos DJ, Ten Hacken NH. Improvement of physical activity after endobronchial valve treatment in emphysema patients. Respir Med. 2016 Aug;117:116-21. doi: 10.1016/j.rmed.2016.06.009. Epub 2016 Jun 9.

  PMID: 27492521 BACKGROUND

• Davey C, Zoumot Z, Jordan S, McNulty WH, Carr DH, Hind MD, Hansell DM, Rubens MB, Banya W, Polkey MI, Shah PL, Hopkinson NS. Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet. 2015 Sep 12;386(9998):1066-73. doi: 10.1016/S0140-6736(15)60001-0. Epub 2015 Jun 23.

  PMID: 26116485 BACKGROUND

• Zoumot Z, Davey C, Jordan S, McNulty WH, Carr DH, Hind MD, Polkey MI, Shah PL, Hopkinson NS. Endobronchial valves for patients with heterogeneous emphysema and without interlobar collateral ventilation: open label treatment following the BeLieVeR-HIFi study. Thorax. 2017 Mar;72(3):277-279. doi: 10.1136/thoraxjnl-2016-208865. Epub 2016 Dec 20.

  PMID: 27999170 BACKGROUND

• Sciurba FC, Ernst A, Herth FJ, Strange C, Criner GJ, Marquette CH, Kovitz KL, Chiacchierini RP, Goldin J, McLennan G; VENT Study Research Group. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med. 2010 Sep 23;363(13):1233-44. doi: 10.1056/NEJMoa0900928.

  PMID: 20860505 BACKGROUND

• Herth FJ, Noppen M, Valipour A, Leroy S, Vergnon JM, Ficker JH, Egan JJ, Gasparini S, Agusti C, Holmes-Higgin D, Ernst A; International VENT Study Group. Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur Respir J. 2012 Jun;39(6):1334-42. doi: 10.1183/09031936.00161611. Epub 2012 Jan 26.

  PMID: 22282552 BACKGROUND

• Skowasch D, Fertl A, Schwick B, Schafer H, Hellmann A, Herth FJ; LIVE Study Investigators. A Long-Term Follow-Up Investigation of Endobronchial Valves in Emphysema (the LIVE Study): Study Protocol and Six-Month Interim Analysis Results of a Prospective Five-Year Observational Study. Respiration. 2016;92(2):118-26. doi: 10.1159/000448119. Epub 2016 Aug 24.

  PMID: 27562904 BACKGROUND

• Criner GJ, Sue R, Wright S, Dransfield M, Rivas-Perez H, Wiese T, Sciurba FC, Shah PL, Wahidi MM, de Oliveira HG, Morrissey B, Cardoso PFG, Hays S, Majid A, Pastis N Jr, Kopas L, Vollenweider M, McFadden PM, Machuzak M, Hsia DW, Sung A, Jarad N, Kornaszewska M, Hazelrigg S, Krishna G, Armstrong B, Shargill NS, Slebos DJ; LIBERATE Study Group. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Respir Crit Care Med. 2018 Nov 1;198(9):1151-1164. doi: 10.1164/rccm.201803-0590OC.

  PMID: 29787288 BACKGROUND

• Kemp SV, Slebos DJ, Kirk A, Kornaszewska M, Carron K, Ek L, Broman G, Hillerdal G, Mal H, Pison C, Briault A, Downer N, Darwiche K, Rao J, Hubner RH, Ruwwe-Glosenkamp C, Trosini-Desert V, Eberhardt R, Herth FJ, Derom E, Malfait T, Shah PL, Garner JL, Ten Hacken NH, Fallouh H, Leroy S, Marquette CH; TRANSFORM Study Team *. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017 Dec 15;196(12):1535-1543. doi: 10.1164/rccm.201707-1327OC.

  PMID: 28885054 BACKGROUND

MeSH Terms

Conditions

Emphysema

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Christina Kutzavitch, PhD

  Pulmonx Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: November 25, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (11)