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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02615431
Other study ID # 15-060
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 19, 2015
Last updated June 9, 2016
Start date November 2015
Est. completion date November 2016

Study information

Verified date November 2015
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

The aim of the present study is to influence the central and obstructive sleep apnoea in patients with severe mitral insufficiency by an interventional MitraClip examination to evaluate.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 34
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient suffer on severe symptomatical mitral insufficience

- male and female patients is planned an interventional MitraClip examination

- Dyspnea with a NYHA (New York Heart Association) II - III

- an high logistic Euro-Score (> 20)

- no execution of surgical intervention because of relevant comorbidities

Exclusion Criteria:

- younger than 18 years

- pregnancy and breast-feeding

- persons without mental ability of capacity to understand and follow the instructions of the investigator

- persons in dependence from the sponsor or working with the sponsor

- participation in other studies

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
MitraClip Intervention


Locations

Country Name City State
Germany University Hospital RWTH Aachen, Department of Medical Clinic I Aachen, 52074

Sponsors (1)

Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Apnoea-Hypopnoea-Index 12 months No
See also
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