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We want
to inform you of a novel new therapy that may be
applicable to patients afflicted with emphysema. This
new treatment option is currently under investigation
at several hospitals worldwide - including the
Thoraxklinik Heidelberg gGmbH.
 The
VENT study will investigate a new, minimally invasive
approach to treating patients with emphysema. This
procedure, developed by Emphasys Medical, Inc.,TM
(www.emphasysmedical.com)
involves bronchoscopically placing small, one-way
valves in the patient’s lung in order to block the
inspiratory airflow into hyperinflated regions of the
lung, while permitting exhaled gas to escape. This
approach may provide some of the clinical benefits of
LVRS without the high risks and costs associated with
such an invasive surgical procedure. In addition, the
valves are removable, allowing the procedure to
potentially be reversible.
Over 100
patients have been treated worldwide using the Emphasys
Endobronchial Valve in an initial pilot study. These
clinical results were compelling enough to warrant
further clinical investigation in a larger randomized
trial.
Eligibility criteria:
Inclusion:
Distribution:
Heterogeneous emphysema
Age:
40 to 75 years
Lung function:
FEV1
< 45% predicted
TLC
> 100% predicted
RV
> 100% predicted
Blood gas:
PaO2
> 45 mmHg on room air
PaCO2
< 50 mmHg
Exclusion:
General:
alpha1-antitrypsin deficiency
smoking in the four month prior
Lung function:
FEV1
< 15% predicted
Other diseases:
Prior lung transplant, LVRS, med. sternotomy, lobectomy
Pulmonary nodule requiring surgery
Clinical suspicion or proven history of pulmonary
hypertension
Systemic disease or neoplasia compromising survival
If you
have any questions regarding this study or would like
to participate feel free to contact us directly at
06221-396-1201.
Similarly, if you would be interested in learning more
about the study, please feel free to have them contact
our institution at:
ralf.eberhardt@thoraxklinik-heidelberg.de .
Regards,
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Prof.
Dr. med. F. Herth
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Chief Investigator
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Dr. med.
R.
Eberhardt
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Investigator
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Thoraxklinik
Heidelberg gGmbh
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Innere
Medizin-Pneumologie
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Amalienstrasse 5
-
69126 Heidelberg
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Tel. 06221-396-0
Email.
ralf.eberhardt@thoraxklinik-heidelberg.de
Net.
www.thoraxklinik-heidelberg.de
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