5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
NCT ID: NCT04161079
Last Updated: 2020-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
12 participants
OBSERVATIONAL
2019-11-08
2020-01-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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MAR population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR)
Mitral valve repair using the MAR performed in clinical investigation 2010-040
Interventions
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Medtentia Annuloplasty Ring (MAR)
Mitral valve repair using the MAR performed in clinical investigation 2010-040
Eligibility Criteria
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Inclusion Criteria
* Subject had a successful MAR implantation in clinical investigation 2010-040.
* Subject is willing to participate in the follow-up study and to comply with the requirements of the Clinical Investigation Plan.
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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Medtentia International Ltd Oy
INDUSTRY
Responsible Party
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Principal Investigators
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Tapio Aalto, MD
Role: PRINCIPAL_INVESTIGATOR
Mehiläinen hospital
Locations
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Mehiläinen hospital
Helsinki, , Finland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Medtentia Company Webpage
Other Identifiers
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2010-040FU5
Identifier Type: -
Identifier Source: org_study_id
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