The Influence of MitraClip on Apnoea Asleep

NCT ID: NCT02615431

Last Updated: 2016-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnoea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MitraClip Intervention

the influence of MitraClip on Apnoea Asleep

MitraClip Intervention

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MitraClip Intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Dreher, MD

Role: PRINCIPAL_INVESTIGATOR

Uniklinik RWTH Aachen, Med. Klinik I

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital RWTH Aachen, Department of Medical Clinic I

Aachen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-060

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CPAP in AF Patients With OSA
NCT04513483 COMPLETED NA
Chronic Evaluation of Respicardia Therapy
NCT01124370 COMPLETED PHASE2