Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)

NCT ID: NCT03104660

Last Updated: 2020-04-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2018-12-31

Brief Summary

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To evaluate the long-term results after transcatheter mitral valve repair

Detailed Description

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Patients with transcatheter mitral valve repair are followed for 10 years to demonstrate efficacy and safety.

Conditions

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Mitral Valve Regurgitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

CE certified mitral valve repair systems
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CE certified mitral valve repair systems

CE certified transcatheter mitral valve repair systems

Group Type EXPERIMENTAL

CE certified mitral valve repair systems

Intervention Type DEVICE

Patients receive a transcatheter mitral valve repair with CE certified transcatheter mitral repair systems.

Interventions

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CE certified mitral valve repair systems

Patients receive a transcatheter mitral valve repair with CE certified transcatheter mitral repair systems.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* mitral valve regurgitation
* transcatheter mitral valve repair

Exclusion Criteria

* no written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Jochen Wohrle

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jochen Woehrle, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ulm

Locations

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University Hospital Ulm

Ulm, , Germany

Site Status

Countries

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Germany

References

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Seeger J, Markovic S, Kessler M, Rottbauer W, Wohrle J. Apixaban After Percutaneous Edge-to-Edge Mitral Valve Repair in Patients With Maintained Sinus Rhythm. JACC Cardiovasc Interv. 2019 Jan 28;12(2):214-216. doi: 10.1016/j.jcin.2018.11.009. No abstract available.

Reference Type RESULT
PMID: 30678801 (View on PubMed)

Seeger J, Muller P, Gonska B, Scharnbeck D, Markovic S, Walcher D, Rottbauer W, Wohrle J. Percutaneous Mitral Valve Repair With the MitraClip in Primary Compared With Secondary Mitral Valve Regurgitation Using the Mitral Valve Academic Research Consortium Criteria. J Invasive Cardiol. 2017 Apr;29(4):145-150.

Reference Type RESULT
PMID: 28368846 (View on PubMed)

Other Identifiers

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CSI-Ulm-TMVR

Identifier Type: -

Identifier Source: org_study_id

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