Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema
Recruiting · NCT04801108 · Interventional (participants receive a specific treatment) · Lead sponsor: Beth Israel Deaconess Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 addition to endobronchial valve (EBV) placement (representing "standard-of-care") in select patients with severe COPD/emphysema and with evidence for \<95% fissure completion between adjacent lung lobes. In select patients, lung fissure completion strategy will be performed by either video-assisted thorascopic surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to reduce collateral ventilation and determine whether or not this experimental strategy will improve outcome following subsequent EBV placement. EBV placement will follow successful VATS-guided or robotic-guided fissure stapling. The study will enroll approximately 20 patients at BIDMC, and outcomes will focus on procedure-related complications, physiological measurements (ex., FEV1 by pulmonary function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed for 3-month period, receiving usual standard of care during the 3 months of follow-up. The goal of this protocol is to determine if elimination of significant collateral lung ventilation between lung lobes is possible, and whether such strategy to eliminate collateral lung ventilation between lobes improves outcomes following subsequent EBV placement (i.e. promotes atelectasis of diseased lung segments) in the management of severe COPD/emphysema in appropriate candidates. For subjects in the medical management control group, upon completion of the 3-month F/U period, they will be eligible for EBV if they choose.
Who can take part
Inclusion criteria
- 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 criteria
- \> 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
Where it is running
1 location listed across 1 US state.
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States