The Influence of MitraClip on Apnoea Asleep | NCT02615431

Studies
The Influence of MitraClip on Apnoea Asleep

NCT02615431

Sponsor

RWTH Aachen University

Status

Unknown status

Last Update Posted

Jun 10, 2016Estimated

Enrollment

34Estimated

Phase

Not provided

Conditions

Sleep Apnoea

Interventions

MitraClip Intervention

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Nov 2016Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Nov 19, 2015

First Submission Date that Met QC Criteria

Nov 24, 2015

First Posted Date

Nov 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2016

Last Update Posted Date

Jun 10, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MitraClip Intervention		the influence of MitraClip on Apnoea Asleep	Other: MitraClip Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MitraClip Intervention	Other		MitraClip Intervention

Measure	Description	Time Frame
Apnoea-Hypopnoea-Index		12 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

male and female patients is planned an interventional MitraClip examination

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Dreher, MD	Uniklinik RWTH Aachen, Med. Klinik I	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital RWTH Aachen, Department of Medical Clinic I		Aachen			Germany

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided