Status:
RECRUITING
Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Pulmonx Corporation
Conditions:
Emphysema or COPD
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The purpose of this protocol is to perform a pilot prospective randomized controlled clinical trial to evaluate the potential role of lung fissure completion strategy (experimental intervention) in ad...
Detailed Description
We plan to approach all EBVs candidates that have \< 95% lobar fissure completion. Once the patient agrees to participate and sign the consent, all the screening information collected as part of the s...
Eligibility Criteria
Inclusion
- Age 40 to 75 years.
- Stable with less than 10mg prednisone (or equivalent) daily.
- Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration.
- Completed a supervised pulmonary rehabilitation program less than equal to 12 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 12 months prior.
- Current pneumococcus vaccination.
- Current influenza vaccination.
- Willing and able to complete protocol required study follow-up assessments and procedures.
Exclusion
- \> 95% fissure completion on high-resolution chest CT-scan (HRCT) or StratX evaluation with a Chartis evaluation negative for collateral ventilation.
- Clinically significant (greater than 4 tablespoons per day) mucus production.
- Myocardial infarction within 6 months of screening.
- Uncontrolled congestive heart failure.
- Three or more pneumonia episodes in last year.
- Three or more COPD exacerbation episodes in the last year.
- Prior lung transplant, LVRS, bullectomy, or lobectomy.
- Clinically significant bronchiectasis.
- Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.
- Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \>45mmHg) or evidence or history of CorPulmonale as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).
- Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).
- Resting bradycardia (\<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT.
- Post-bronchodilator FEV1 less than 15% or greater than 45% of the predicted value at screening.
- TLC less than 100% predicted (determined by body plethysmography at screening).
- RV less than 150% predicted in patients with heterogeneous emphysema or less than 200% predicted in patients with homogeneous emphysema (determined by body plethysmography at screening).
- DLCO less than 20% of the predicted value at screening.
- Post-rehabilitation 6-minute walk distance less than 100 meters or greater than 450 meters at screening.
- PaCO2 greater than 50mmHg on room air at screening.
- PaO2 less than 45mmHg on room air at screening
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04801108
Start Date
August 1 2021
End Date
August 1 2026
Last Update
April 6 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215