The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 29
- Primary Endpoint
- Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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- •Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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.
Outcomes
Primary Outcomes
Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure
Time Frame: 12 months
The primary safety endpoint will be the incidence of device-related and procedure-related pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure.
Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure
Time Frame: 36 months
An additional analysis will present the rate (per patient-year) of TAEsSI.
Secondary Outcomes
- 45-day pneumothorax rate(45 days)
- Survival rate over 24 months(24 months)