[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Isabelle Opitz, Professor, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100403734","surgical-compared-to-bronchoscopic-lung-volume-reduction-in-patients-with-severe-emphysema-100403734",false,"NCT04537182","Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema","Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema: an International Multi-center Randomized Controlled Trial","SINCERE","Inclusion Criteria:\n\n* Patients suffering from emphysema (all morphologies, uni- or bilateral distribution) potentially qualifying for both study procedures, LVRS or BLVR (if possible, perfusion scintigraphy within \\\u003C 6 month of screening, CT scan within \\\u003C 4 months of screening)\n* Age ≥ 30 and ≤ 80 years\n* Body Mass Index (BMI) ≥ 16, but ≤ 35 kg\u002Fm2\n* Non-smoking for 3 months prior to screening interview\n* Patient is able to understand and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n* FEV1 more than 50% predicted\n* TLC less than 100 % predicted, RV less than 175% predicted, RV\u002FTLC less than 58% predicted, and DLCO ≤ 20% predicted in homogeneous emphysema and DLCO ≤ 15% in heterogeneous emphysema, respectively\n* PaO2 ≤ 6.0 kPa (45mm Hg) at ambient air (only applicable for homogeneous morphology!)\n* PaCO2 ≥ 6.6 kPa (50 mmHg) at ambient air (only applicable for homogeneous morphology!)\n* Patients with incomplete interlobar fissures as revealed by quantitative computed tomography analysis with StratX® (fissure completeness ≤ 80%)\n* Patients with collateral ventilation as evidenced by bronchoscopic Chartis® measurement (only performed if fissure completeness according to StratX® is \\\u003C 95%)\n* 6-minute walking distance ≥ 470m\n* More than two COPD exacerbation episodes requiring hospitalization in the last year\n* More than two instances of pneumonia episodes in the last year\n* Unplanned weight loss ≥ 10% within 90 days prior to enrollment\n* Pulmonary hypertension as evidenced by Delta Psyst RV-RA \\> 35 mmHg on recent echocardiography (within 3 months prior to screening) and confirmed by RHC (mPAP ≥ 35 mmHg) and signs of moderate to severe RV dysfunction.\n* Evidence of left ventricular ejection fraction (LVEF) less than 45% on recent echocardiography (within 3 months prior to screening)\n* History of exercise-related syncope\n* Myocardial infarction or congestive heart failure within 6 months of screening\n* Clinically significant arrhythmias that might put the patient at risk in regard to the interventions\n* Prior LVR (any method), bullectomy, or lobectomy\n* Clinically significant bronchiectasis with expectoration of ≥ 2 tablespoons\u002Fday.\n* Pulmonary nodule requiring surgery\n* Unable to safely discontinue anticoagulants or dual antiplatelet therapy for 7 days\n* Patients with a life expectancy of less than one year","ALL","30 Years","80 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"NA","The investigators plan to perform a randomized controlled trial that compares bilateral lung volume reduction surgery (LVRS) with bronchoscopic lung volume reduction (BLVR) using endobronchial valves in terms of efficacy and patient safety.",[28],"Emphysema",[30,31,32,33,34],"LVRS","BLVR","endobronchial valves","heterogeneous empyhsema","non-heterogeneous emphysema","RECRUITING","2024-05-07",{"date":38,"type":39},"2024-05-08","ACTUAL",{"date":41,"type":39},"2020-09-01",{"date":43,"type":22},"2028-03",{"name":45,"class":46},"Isabelle Opitz, Professor, MD","OTHER",6,""]