Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Fun… (NCT05775588) | Clinical Trial Compass
CompletedNot Applicable
Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function
China22 participantsStarted 2023-03-27
Plain-language summary
The goal of this type of study: clinical trial is to evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function.
Participants will undergo Lung volume reduction surgery with endobronchial valve implantation.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with Chronic Obstructive Pulmonary Disease
* 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:
* PaCO2\>8.0 kPa, or PaO2\<6.0 kPa
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Baseline ventricular volume
Timeframe: Baseline
2
Ventricular volume （6 months after surgery）
Timeframe: 6 months after surgery
3
Ventricular volume（12 months after surgery）
Timeframe: 12 months after surgery
4
Baseline FEV1
Timeframe: Baseline
5
FEV1 （6 months after surgery）
Timeframe: 6 months after surgery
6
FEV1（12 months after surgery）
Timeframe: 12 months after surgery
7
Baseline left Ventricular Ejection Fractions
Timeframe: Baseline
8
Left Ventricular Ejection Fractions （6 months after surgery）