The Influence of MitraClip on Apnoea Asleep

• Conditions: Sleep Apnoea
• Interventions: Other: MitraClip Intervention

• Registration Number: NCT02615431
• Lead Sponsor: RWTH Aachen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-11
• Study Start: 2015-11
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Last Update Submitted: 2016-06-09
• Last Update Posted: 2016-06-10
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MitraClip Intervention	MitraClip Intervention	the influence of MitraClip on Apnoea Asleep

Primary Outcome Measures

Name	Time	Method
Apnoea-Hypopnoea-Index	12 months

Trial Locations

Locations (1)

University Hospital RWTH Aachen, Department of Medical Clinic I; 🇩🇪 Aachen, 52074, Germany