Status:
UNKNOWN
Right Ventricular Diastolic Dysfunction
Lead Sponsor:
University Hospital, Montpellier
Conditions:
COPD
Emphysema
Eligibility:
All Genders
40+ years
Brief Summary
Heart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are very commonly associated. Emphysema by increasing intrathoracic pressure appears to affect cardiac function....
Eligibility Criteria
Inclusion
- Inclusion criteria:
- At least 40 years
- A smoking history
- Smoking cessation ≥ 6 months
- FEV1/FVC ≤ 0,7
- Severe emphysema (destruction ≥ 50%)
- Peak tricuspid regurgitation velocity \< 2,8 m/s or presence of other echocardiographic "PH signs"
- 15% ≤ FEV1post ≤ 50%
- Residual volume ≥ 175% predicted
- TLC ≥ 100% predicted
- Optimal medical management
- 150m ≤ 6MWD ≤ 500m
- mMRC ≥ 2
- Physical activity ≥ 2/Week (≥ 30minutes)
- Exclusion criteria:
- ≥2 hospitalizations/year for EACOPD
- Recent EACOPD (≤ 3months)
- ≥ 50ml mucus/day
- PAPm ≥35mmHg
- PaCO2 ≥ 55mmHg
- Bubble ≥ 1/3 hemithorax
- Lung fibrosis, bronchiectasis, lung cancer, homolateral surgery
- Left ventricular ejection fraction ≤ 45%, unstable heart disease
- Life expectancy ≤ 1 year
- Contraindication to anesthesia
- Allergy to nitinol or silicone
- Corticotherapy ≥ 10mg/day
- Patient under legal protection
Exclusion
Key Trial Info
Start Date :
July 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04467242
Start Date
July 20 2020
End Date
June 1 2022
Last Update
December 1 2020
Active Locations (1)
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1
Uh Montpellier
Montpellier, France, 34295