Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function
NCT ID: NCT05775588
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-03-27
2024-12-31
Brief Summary
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Participants will undergo Lung volume reduction surgery with endobronchial valve implantation.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lung volume reduction surgery group
Lung volume reduction surgery with endobronchial valve implantation
the patient would undergo Lung volume reduction surgery with endobronchial valve implantation
Interventions
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Lung volume reduction surgery with endobronchial valve implantation
the patient would undergo Lung volume reduction surgery with endobronchial valve implantation
Eligibility Criteria
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Inclusion Criteria
* FEV1 ≤ 45% pred and FEV1/FVC\<70%
* TLC\>100% pred and RV\>175% pred
* CAT score≥18
* Emphysema damage\>50%
* Complete interlobar fissure \>95% based on quantitative analysis of CT measurement
* No smoking\>6 months
* Sign the informed consent form
Exclusion Criteria
* 6-minute walk test\<160m
* Obvious chronic bronchitis, bronchiectasis or other infectious pulmonary diseases
* More than 3 hospitalizations for pulmonary infection in the past 12 months before baseline assessment
* Previous lobectomy, LVRS or lung transplantation
* LVEF\<45% and or RVSP\>50mmHg
* Anticoagulant therapy that cannot be stopped before surgery
* Patients with obvious immune deficiency
* Participated in other lung drug studies within the first 30 days of this study
* Pulmonary nodules requiring intervention
* Any disease or condition that interferes with the completion of the initial or subsequent assessment
18 Years
90 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Gang Hou
Principal Investigator
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-NHLHCRF-LX-01-0202-1
Identifier Type: -
Identifier Source: org_study_id
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