MitraClip® Registry

NCT ID: NCT02033811

Last Updated: 2020-02-07

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

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2030-12-31

Brief Summary

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Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients.

The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end observational study to assess the characteristics and outcomes patients with severe mitral regurgitation undergoing PMVR.

Detailed Description

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Conditions

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Mitral Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* severe mitral regurgitation
* percutaneous mitral valve repair (PMVR) with the MitraClip® system

Exclusion Criteria

* \< 18 years
* Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinik für Kardiologie, Pneumologie und Angiologie

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Director Division of Cardiology, Pulmonary Disease and Vascular Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Malte Kelm, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Malte Kelm, MD

Role: STUDY_CHAIR

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Locations

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Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine

Düsseldorf, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Malte Kelm, MD

Role: CONTACT

0049 211 81 18800

Facility Contacts

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Malte Kelm, MD

Role: primary

References

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Herbrand T, Eschenhagen S, Zeus T, Kehmeier E, Hellhammer K, Veulemans V, Kelm M, Balzer J. Acute reverse annular remodeling during MitraClip(R) therapy predicts improved clinical outcome in heart failure patients: a 3D echocardiography study. Eur J Med Res. 2017 Sep 20;22(1):33. doi: 10.1186/s40001-017-0273-x.

Reference Type DERIVED
PMID: 28931437 (View on PubMed)

Rammos C, Zeus T, Balzer J, Veulemans V, Hellhammer K, Niebel S, Kelm M, Rassaf T. Left Atrial and Left Ventricular Function and Remodeling Following Percutaneous Mitral Valve Repair. J Heart Valve Dis. 2016 May;25(3):309-319.

Reference Type DERIVED
PMID: 27989041 (View on PubMed)

Hellhammer K, Zeus T, Balzer J, van Hall S, Rammos C, Wagstaff R, Kelm M, Rassaf T. Safety and efficacy of percutaneous mitral valve repair using the MitraClip(R) system in patients with diabetes mellitus. PLoS One. 2014 Nov 6;9(11):e111178. doi: 10.1371/journal.pone.0111178. eCollection 2014.

Reference Type DERIVED
PMID: 25375257 (View on PubMed)

Related Links

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Other Identifiers

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MitraClip® Registry

Identifier Type: -

Identifier Source: org_study_id

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