The Influence of MitraClip on Apnoea Asleep (MiClAS)

June 9, 2016 updated by: RWTH Aachen University

the Influence of MitraClip on Apnoea Asleep

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, 52074, Germany
        • University Hospital RWTH Aachen, Department of Medical Clinic I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

male and female patients is planned an interventional MitraClip examination

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MitraClip Intervention
the influence of MitraClip on Apnoea Asleep
Other: MitraClip Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Apnoea-Hypopnoea-Index
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Michael Dreher, MD, Uniklinik RWTH Aachen, Med. Klinik I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Estimate)

June 10, 2016

Last Update Submitted That Met QC Criteria

June 9, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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