Evaluation of the Spiration Valve for Emphysema to Improve Lung Function

Overview

About this study

This is a multicenter, prospective, randomized, controlled study designed to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.

The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Subject has severe and heterogeneous emphysema with severe dyspnea
Subject certified to meet the criteria of ATS/ERS guidelines for management of stable COPD
Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m
Subject has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study
Pulmonary Function Testing Results (PFT's) demonstrate
- FEV1 ≤ 45% of predicted
- RV ≥ 150% of predicted
- TLC ≥ 100% of predicted

Exclusion Criteria

Patient has a BMI < 15 kg/m2 or > 35 kg/m2
Arterial Blood Gas Level (ABG) indicates
- PCO2 > 50 mm Hg
- PO2 < 45 mm Hg on room air
Subject has a diffuse emphysema pattern or α1-antitrypsin deficiency
Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day
Subject has an active asthma (>15 mg of prednisone daily)
Giant bulla (> 1/3 volume of lung)
Pulmonary hypertension
Subject with prior major lung surgery or recent hospitalization for COPD exacerbation or respiratory infection

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator Jorge Mallea, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Jorge Mallea, M.D.

Closed for enrollment

More information

Publications

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