NCT02615431

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 10, 2016

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 19, 2015

Last Update Submit

June 9, 2016

Conditions

Sleep Apnoea

Outcome Measures

Primary Outcomes (1)

  • Apnoea-Hypopnoea-Index

    12 months

Study Arms (1)

MitraClip Intervention

the influence of MitraClip on Apnoea Asleep

Other: MitraClip Intervention

Interventions

MitraClip InterventionOTHER
MitraClip Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

male and female patients is planned an interventional MitraClip examination

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital RWTH Aachen, Department of Medical Clinic I

Aachen, Germany

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Michael Dreher, MD

    Uniklinik RWTH Aachen, Med. Klinik I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 26, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 10, 2016

Record last verified: 2015-11

Locations

DE(1)