Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry

NCT ID: NCT05332782

Last Updated: 2022-04-18

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

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-01-01

Brief Summary

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This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).

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

RETROSPECTIVE

Study Groups

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M-TEER

Patients with primary mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* clinically significant primary mitral regurgitation
* patient underwent M-TEER
* echocardiography data at baseline, procedure and follow-up
* follow-up of at least 12 months

Exclusion Criteria

* age under 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Kalbacher, MD

Role: PRINCIPAL_INVESTIGATOR

University Heart & Vascular Center Hamburg

Locations

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Montefiore Medical Center

New York, New York, United States

Site Status RECRUITING

Centre Hospitalier de Bordeaux

Bordeaux, , France

Site Status RECRUITING

Université Lille, Inserm, Centre Hospitalier Universitaire de Lille

Lille, , France

Site Status RECRUITING

University Hospital of Rennes, Centre Hospitalier de Rennes

Rennes, , France

Site Status RECRUITING

University Heart & Vascular Center Hamburg

Hamburg, , Germany

Site Status RECRUITING

Klinikum der Universität München

Munich, , Germany

Site Status RECRUITING

Countries

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United States France Germany

Central Contacts

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Benedikt Koell, MD

Role: CONTACT

+4915222815230

Sebastian Ludwig, MD

Role: CONTACT

+491522816168

Facility Contacts

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Azeem Latib, MD

Role: primary

Andrea Scotti, MD

Role: backup

Thomas Modine, MD, PhD

Role: primary

Augustin Coisne, MD

Role: primary

Erwan Donal, MD

Role: primary

Benedikt Koell, MD

Role: primary

+4915222815230

Sebastian Ludwig, MD

Role: backup

Jörg Hausleiter, MD

Role: primary

Other Identifiers

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PRIME-MR

Identifier Type: -

Identifier Source: org_study_id

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