STRIVE Post-Market Registry Study

Study Overview
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Brief Summary
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This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.

Detailed Description
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This post-market study is a single-arm, prospective, multi-center Registry. It is designed to assess 36-month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of Spiration Valve System therapy for the treatment of severe emphysema in the United States. Subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant.

Official Title
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The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema

Conditions
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Emphysema

Intervention / Treatment
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* Device: Spiration Valve System (SVS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation. Subjects must understand and voluntarily sign an informed consent form. Exclusion Criteria: Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll. Subjects who have incomplete screening or baseline data.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Spiration Valve System (SVS)|Spiration Valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation. The Spiration Valve is loaded in the deployment catheter, then passed through the channel of a flexible bronchoscope and deployed at the intended target location. The SVS device is designed to relieve the symptoms of shortness of breath and hyperinflation associated with severe emphysema without surgery.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure |  | 12 months | 
| Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 45-day pneumothorax rate, defined as pneumothorax requiring surgical intervention, or prolonged air leak > 7 days defined as the time from chest tube insertion to the time the air leak is not present |  | 45 days | 
| Survival rate over 24 months compared to the EMPROVE study control cohort |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emphysema, Chronic obstructive pulmonary disease (COPD), Spiration valve system