Clinical trial NCT04186546: Zephyr Valve Registry (ZEVR)
Official title: Zephyr Valve Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Emphysema
Keywords: emphysema
endobronchial valve
treatments
pulmonary rehabilitation
lung volume reduction
Lead sponsor: Pulmonx Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Incidence Rate of Pneumothorax from Baseline to 45-days post-procedure
timeFrame: Baseline to 45-days post-procedure
measure: Incidence Rate of Serious Adverse Events (SAEs) of Interest from Baseline to 3 years post-procedure
timeFrame: Baseline to 3 years post-procedure
Secondary outcomes:
measure: Absolute Change in Treated Lobar Volume Reduction (TLVR) after 45-days post-procedure
timeFrame: At baseline and after 45-days post-procedure
measure: Percent Change in Treated Lobar Volume Reduction (TLVR) after 45-days post-procedure
timeFrame: At baseline and after 45-days post-procedure
measure: 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
timeFrame: At baseline, 6-months, 12-months, 24-months and 36-months post-procedure
measure: 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
timeFrame: At baseline, 6-months, 12-months, 24-months and 36-months post-procedure
measure: 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
timeFrame: At baseline, 6-months, 12-months, 24-months and 36-months post-procedure
measure: 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
timeFrame: At baseline, 6-months, 12-months, 24-months and 36-months post-procedure
measure: Absolute Change in Six-Minute Walk Distance (6MWD) from baseline to 6-months and 12-months post-procedure
timeFrame: At baseline, 6-months and 12-months
measure: Percent Change in Six-Minute Walk Distance (6MWD) from baseline to 6-months and 12-months post-procedure
timeFrame: At baseline, 6-months and 12-months
measure: Absolute Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from baseline to 6-months and 12-months post-procedure
timeFrame: At baseline, 6-months and 12-months
measure: Percent Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from baseline to 6-months and 12-months post-procedure
timeFrame: At baseline, 6-months and 12-months
measure: Absolute Change in BODE Index Total Score from baseline to 6-months and 12-months post-procedure
timeFrame: At baseline, 6-months and 12-months
measure: Percent change in BODE Index Total Score from baseline to 6-months and 12-months post-procedure
timeFrame: At baseline, 6-months and 12-months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Winfield
country: United States
facility: Northwestern Medicine
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: DuBois
country: United States
facility: The Lung Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Fairfax
country: United States
facility: Inova Health
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert Memorial-Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Pulmonx Corporation
name: Christina Kutzavitch, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.