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EmphysemaZEVRNCT04186546

Zephyr Valve Registry (ZEVR)

An observational study of Emphysema, run by Pulmonx Corporation at 11 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Emphysema
What is being tested?
Zephyr Valve Procedure
Type of treatment
Medical device
How many people
150 participants
Where
11 sitesUnited States
Study dates
25 Nov 2019to 31 Dec 2026
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • University of Chicago

    Chicago, Illinois, 60637

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • The Lung Center

    DuBois, Pennsylvania, 15801

  • Inova Health

    Fairfax, Virginia, 22031

  • Houston Methodist

    Houston, Texas, 77030

  • Froedtert Memorial-Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15123

  • Northwestern Medicine

    Winfield, Illinois, 60190

Other trials in United States

About this study

Official title: Zephyr Valve Registry

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.

Read the 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.

Conditions
Emphysema
Being tested
Zephyr Valve Procedure
Keywords
emphysema, endobronchial valve, treatments, pulmonary rehabilitation, lung volume reduction
Medical subject headings
Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zephyr Valve ProcedureDevice

    Also called Zephyr Endobronchial Valve, Endobronchial Valve, Bronchoscopic Lung Volume Reduction, BLVR

    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.

Study groups in NCT04186546
Study groupRoleWhat they receive
CasesZephyr Valve Procedure
Receives: Device: Zephyr Valve Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 45-days post-procedure

  2. 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

    Measured: Baseline to 3 years post-procedure

Secondary outcomes (12)

  1. Absolute Change in Treated Lobar Volume Reduction (TLVR) 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.

    Measured: At baseline and after 45-days post-procedure

  2. Percent Change in Treated Lobar Volume Reduction (TLVR) 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.

    Measured: At baseline and after 45-days post-procedure

  3. 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

    The mean absolute change in FEV1(L) relative to Baseline at 6-months, 12-months, 24-months and 36-months post procedure

    Measured: At baseline, 6-months, 12-months, 24-months and 36-months post-procedure

  4. 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

    The mean percent change in FEV1(L) relative to Baseline at 6-months, 12-months, 24-months and 36-months post procedure

    Measured: At baseline, 6-months, 12-months, 24-months and 36-months post-procedure

  5. 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

    The mean absolute change in FEV1(% Predicted) relative to Baseline at 6-months, 12-months, 24-months and 36-months post procedure.

    Measured: At baseline, 6-months, 12-months, 24-months and 36-months post-procedure

  6. 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

    Mean percent change in FEV1(% Predicted) relative to Baseline at 6-months, 12-months, 24-months and 36-months post-procedure

    Measured: At baseline, 6-months, 12-months, 24-months and 36-months post-procedure

  7. Absolute Change in Six-Minute Walk Distance (6MWD) from baseline to 6-months and 12-months post-procedure

    Mean absolute change in the 6MWD from Baseline to 6-months and 12-months post-procedure.

    Measured: At baseline, 6-months and 12-months

  8. Percent Change in Six-Minute Walk Distance (6MWD) from baseline to 6-months and 12-months post-procedure

    Mean percent change in the 6MWD from Baseline to 6-months and 12-months post-procedure.

    Measured: At baseline, 6-months and 12-months

  9. Absolute Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from baseline to 6-months and 12-months post-procedure

    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.

    Measured: At baseline, 6-months and 12-months

  10. Percent Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from baseline to 6-months and 12-months post-procedure

    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.

    Measured: At baseline, 6-months and 12-months

  11. Absolute Change in BODE Index Total Score from baseline to 6-months and 12-months post-procedure

    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.

    Measured: At baseline, 6-months and 12-months

  12. Percent change in BODE Index Total Score from baseline to 6-months and 12-months post-procedure

    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.

    Measured: At baseline, 6-months and 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2019
  2. Study start25 Nov 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04186546
Sponsor's protocol ID
630-0024-01
Acronym
ZEVR
Status last verified
Sep 2026
First submitted
2 Dec 2019
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27580428

  • 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.

    PubMed 26650153

  • 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.

    PubMed 27974713

  • 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.

    PubMed 27492521

  • 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.

    PubMed 26116485

  • 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.

    PubMed 27999170

  • 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.

    PubMed 20860505

  • 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.

    PubMed 22282552

  • 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.

    PubMed 27562904

  • 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.

    PubMed 29787288

  • 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.

    PubMed 28885054

Questions about this trial

What is this clinical trial studying?

An observational study of Emphysema, run by Pulmonx Corporation at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate of Pneumothorax from Baseline to 45-days post-procedure (time frame: Baseline to 45-days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04186546, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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