The Influence of MitraClip on Apnoea Asleep

Sleep Apnoea Clinical Trial

— MiClAS  

Official title:

the Influence of MitraClip on Apnoea Asleep

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02615431
• Other study ID #: 15-060
• 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

• Apnea
• Sleep Apnoea

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