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Trial record 4 of 31 for:    mitraclip

The Influence of MitraClip on Apnoea Asleep (MiClAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT02615431
First received: November 19, 2015
Last updated: June 9, 2016
Last verified: November 2015
  Purpose
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.

Condition Intervention
Sleep Apnoea
Other: MitraClip Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: the Influence of MitraClip on Apnoea Asleep

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Apnoea-Hypopnoea-Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: November 2015
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MitraClip Intervention
the influence of MitraClip on Apnoea Asleep
Other: MitraClip Intervention

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
male and female patients is planned an interventional MitraClip examination
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02615431

Locations
Germany
University Hospital RWTH Aachen, Department of Medical Clinic I
Aachen, 52074, Germany
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Michael Dreher, MD Uniklinik RWTH Aachen, Med. Klinik I
  More Information

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02615431     History of Changes
Other Study ID Numbers: 15-060 
Study First Received: November 19, 2015
Last Updated: June 9, 2016
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on December 08, 2016