Trial Information

Summary: The VITAL- Valve Intervention Treatment Trial

Summary: The VITAL- Valve Intervention Treatment Trial. A clinical trial is underway utilizing an investigational device intended to improve the over all health status and quality of life for people living with emphysema.

This is a randomized blinded study, which means that participants will not know which group they will be assigned to, the valve treatment group or the control group. The participants assigned to the valve treatment group will have an investigational medical device implanted in their lungs with an instrument known as a bronchoscope. This procedure is done without an incision. These small, umbrella shaped valves are designed to redirect airflow to healthier areas of the lungs. At the completion of the 6 month study and the follow up visits, participants in the control group will be eligible to be evaluated for valve treatment.

Inclusion
Ages 40 to 74
Candidates have upper lobe, severe emphysema
Must be able to participate in standard exercise testing
Willing to abstain from cigarette smoking for 4 months prior and during
the entire study
Willing to participate in a randomized, blinded study and complete the
required follow-up visits during the study period.
Willing to participate in up to 4 daily visits to a nearby medical center
for baseline health assessment tests.
Willing to have a minimum of one overnight stay in the hospital

Exclusion
Evidence of another co-existing major medical disease
Unable to tolerate, flexible bronchoscopy procedures
Active asthma, chronic bronchitis
Diffuse emphysema pattern, a1-antitrypsin deficiency
Has had prior lung volume reduction surgery

For more information about the
VITAL- Valve Intervention Treatment Trial
click on the link: www.spiration.com

University of Virginia Health System
IRB-HSR #12648


Contact:

Peggie Donowitz RN
University of Virginia
School of Medicine
Pulmonary & Critical Care, Internal Medicine
Box 800546
Charlottesville, VA 22908
Telephone: 434-982-1801
Fax: --
Email: mew5u@virginia.edu



www.healthsystem.virginia.edu/clinical_trials

If you would like to learn more about participating in this study, please send an e-mail message using the form below.