Conversion of collateral ventilation in CV-positive emphysema patients before endobronchial valve treatment - a pilot study (*MIND THE GAP CROSSING BORDERS*)
- Conditions
- COPDepmphysema10038716
- Registration Number
- NL-OMON49774
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1. Diagnosis of emphysema
2. Subjects of both genders of at least 35 years of age at the time of the
baseline visit.
3. Understand and voluntarily sign a patient informed consent form.
4. 15 % predicted <= FEV1 <= 50% predicted.
5. RV >= 175% predicted, and TLC >= 100% predicted and RV/TLC >= 55% predicted.
6. 6MWD >= 140 meters.
7. Dyspnea score of >=2 on the mMRC scale of 0-4.
8. Non-smoker > 6 months prior to signing the informed consent.
9. Chartis CV positive between target and ipsilateral lobe
1. Evidence of active pulmonary infection.
2. Evidence of clinically significant bronchiectasis.
3. History of more than 3 exacerbations with hospitalizations over the past 12
months.
4. Subject has DLCO <20% of predicted.
5. Myocardial infarction or other relevant cardiovascular events in the past 6
months.
6. Prior lung surgery, Lung volume reduction surgery, lung transplantation,
lobectomy, or pneumonectomy.
7. Prior endoscopic lung volume reduction.
8. Unstable pulmonary nodule requiring follow-up
9. Pregnant of nursing women.
10. Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 <
6.0kPa, both measured on room air.
11. Any disease with high probability of mortality within 24 months.
12. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant
therapy (such as LMWH or coumarins).
13. Patient was involved in other pulmonary drug studies within 30 days prior
to this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Feasibility:<br /><br>A) Being able to access the region of the fissure defect<br /><br>B) Evidence of targeted lung volume reduction (TLVR >563 ml) on CT scan at 6<br /><br>weeks and 3 months Follow Up. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety: The number and type of procedure-related (serious) adverse events<br /><br>within 3 months after the procedure.<br /><br>Effectiveness:<br /><br>- Change in TLVR, lung function, exercise capacity and quality of life at 3<br /><br>months Follow Up.<br /><br>- Conversion of CV(+) into CV(-) lobes</p><br>