Zephyr Valve Japan Post-Marketing Surveillance

Summary

This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months.

Eligibility

Inclusion Criteria:

1. Patient is deemed eligible for BLVR using Zephyr Valve, as determined by their treating physician in accordance with Japanese guidelines and approved instruction for use. These include:

   * Recent respiratory rehabilitation completed within the last 6 months
   * Not actively smoking (for at least 4 months)
   * TLC ≥ 100%
   * RV ≥ 175%
   * FEV1 15-45% post-bronchodilator
   * 6MWD 100-500 m
   * mMRC score ≥ 2
   * No coagulation disorder
   * No evidence of active respiratory infection
2. Patient has little to no collateral ventilation (CV-) between the target and ipsilateral lobe as confirmed by Chartis prior to undergoing BLVR.
3. Patient is willing and able to provide informed consent to allow data collection.

Exclusion Criteria: None

Conditions3

Browse More Trials