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The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.
This is a multi-center, single-arm, prospective Registry to be conducted at a minimum of 12 study centers. 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.
Patients prescribed the Zephyr Valve treatment 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 post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zephyr Valve treatment | Patients undergoing the Zephyr Valve treatment for emphysema/COPD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zephyr Valve | Device | Subjects prescribed Zephyr Valve treatment for their emphysema/COPD and treated with the Zephyr Valves. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in 1 second (FEV1) | The percent of patients achieving an improvement in the post-bronchodilator FEV1 of ≥12% at 12-months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treated Lobar Volume Reduction (TLVR) | Treated Lobar Volume Reduction (TLVR) assessed by High Resolution Computed Tomography (HRCT) at 45-days. | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator | Absolute Change in FEV1 from Baseline to 6-months, 12-months, 24-months and 36-months. | Baseline, 6-months, 12-months, 24-months and 36-months |
| Percent Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator |
Inclusion Criteria:
Exclusion Criteria:
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This is an all-comers Registry. Physicians at participating study centers will invite consecutive patients who are prescribed Zephyr Valve treatment to participate in the Registry and allow data collection.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Egenod, MD | Hôpital Dupuytren (CHRU Limoges) | Principal Investigator |
| Dennis McHugh | Pulmonx Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital La Cavale Blanche | Brest | France | ||||
| Hôpital François Mitterrand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29787288 | 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. | |
| 28885054 |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Percent change in FEV1 from Baseline to 6-months, 12-months, 24-months and 36-months. |
| Baseline, 6-months, 12-months, 24-months and 36-months |
| Absolute Change in Residual Volume (RV) | Absolute Change in Residual Volume (RV) from Baseline to 6-months, 12-months, 24-months and 36-months. | Baseline, 6-months, 12-months, 24-months and 36-months |
| Percent Change in Residual Volume (RV) | Percent change in Residual Volume (RV) from Baseline to 6-months, 12-months, 24-months and 36-months. | Baseline, 6-months, 12-months, 24-months and 36-months |
| Absolute Change in St. George's Respiratory Questionnaire (SGRQ) Total Score | Absolute change in St. George's Respiratory Questionnaire (SGRQ) from Baseline to 6-months and 12-months. The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations. | Baseline, 6-months and 12-months |
| Percent Change in St. George's Respiratory Questionnaire (SGRQ) Total Score | Percent change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to 6-months and 12-months. The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations. | Baseline, 6-months and 12-months |
| Absolute Change in Modified Medical Research Council (mMRC) | Absolute Change in the Modified Medical Research Council (mMRC) Dyspnea Scale from Baseline to 6-months and 12-months. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations. | Baseline, 6-months and 12-months |
| Percent Change in Modified Medical Research Council (mMRC) | Percent change in the Modified Medical Research Council (mMRC) Dyspnea Scale from Baseline to 6-months and 12-months. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations. | Baseline, 6-months and 12-months |
| Absolute Change in Six-Minute Walk Distance (6MWT) | Absolute change in Six-Minute Walk Distance (from 6MWT) from Baseline to 6-months and 12-months. | Baseline, 6-months and 12-months. |
| Percent Change in Six-Minute Walk Distance (6MWT) | Percent change in Six-Minute Walk Distance (from 6MWT) from Baseline to 6-months and 12-months. | Baseline, 6-months and 12-months. |
| Dijon |
| France |
| Hôpital Nord | Latronche | France |
| Hôpital Calmette | Lille | France |
| Hôpital Dupuytren | Limoges | France |
| Hôpital Arnaud de Villeneuve | Montpellier | France |
| Hôpital Bichat | Paris | France |
| Hôpital Cochin | Paris | France |
| Hôpital Charles Nicolle | Rouen | France |
| Hôpital Nord | Saint-Etienne | France |
| Nouvel Hôpital Civil | Strasbourg | France |
| Hôpital Larrey | Toulouse | France |
| 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. |
| 27580428 | Background | 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. |
| 26650153 | 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. |
| 27974713 | 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. |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |