Resumen

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.

Edad: 18 años o más

Género: Todos

Fecha de inicio: 10/09/2021

Fecha de finalización principal (estimada): 12/01/2026

Fecha estimada de finalización del estudio: 10/01/2029

Acepta voluntarios sanos: No

Propósito y descripción del ensayo

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.

Criterios de elegibilidad

Edad: 18 años o más

Género: Todos

Acepta voluntarios sanos: No

Criterios de inclusión:

1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.

2. Subjects must understand and voluntarily sign an informed consent form.

Criterios de exclusión:

1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.

2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.

3. Subjects who have incomplete screening or baseline data.