The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused emphysema. The hypothesis is that emphysema in AATD patients shows similar tissue destruction profile was well as symptoms and thus will respond favorably to LVRC treatment, demonstrating improvement in lung function, exercise capacity, and quality of life relative to their baseline status.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Endoscopic Lung Volume Reduction
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark
University Hospital of Saarland
Homburg, Saarland, Germany
symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) compared to the 6 months Follow-up Visit
Quality of Life
Time frame: 6 months
Percent change in FEV1 from Baseline (Pre-Treatment Visit)
Lung function
Time frame: 6 and 12 months
Decrease in the Residual Volume and the RV/TLC ratio
Lung function
Time frame: 6 and 12 months
Improvement in the 6 minute walk distance
6MWT
Time frame: 6 and 12 months
Changes in mMRC Dyspnoe Scale
mMRC
Time frame: 6 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.