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MitraClip® After Surgical Mitral Valve Repair

NCT ID: NCT02853955

Last Updated: 2016-09-01

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-11-30

Brief Summary

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Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to evaluate the effectiveness and durability of this minimally invasive treatment option in this subset of patients.

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Detailed Description

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In this multicenter retrospective analysis of MitraClip® cases after MVR the effectiveness and durability of this minimally invasive treatment option in this subset of patients will be evaluated.

Conditions

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Mitral Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Percutaneous edge-to-edge repair of the mitral valve

MitraClip in patients with recurrent MI after surgical mitral valve repair.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients with recurrent mitral regurgitation treated with a MitraClip®.

Exclusion Criteria

* Patient with endocarditis,
* Patients with torn mitral valve ring.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LMU Klinikum

OTHER

Sponsor Role lead

Responsible Party

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Daniel Braun, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jörg Hausleiter, MD

Role: STUDY_CHAIR

LMU Munich

Locations

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Munich University Hospital

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Daniel Braun, MD

Role: CONTACT

[email protected]
+49 89 4400 ext. 73052

Jörg Hausleiter, MD

Role: CONTACT

[email protected]
+49 89 4400 ext. 72360

Facility Contacts

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Daniel Braun, MD

Role: primary

[email protected]
+49894400 ext. 73052

Joerg Hausleiter, MD

Role: backup

[email protected]
+49894400 ext. 72360

Other Identifiers

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GE IDE MucS001-16

Identifier Type: -

Identifier Source: org_study_id

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