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5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults

NCT04161079 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2020-09-28

Study results available
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Summary

Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in clinical investigation 2010-040 performed during June 2011 - April 2016.

Conditions

  • Mitral Regurgitation
  • Mitral Insufficiency

Interventions

DEVICE

Medtentia Annuloplasty Ring (MAR)

Mitral valve repair using the MAR performed in clinical investigation 2010-040

Sponsors & Collaborators

  • Medtentia International Ltd Oy

    lead INDUSTRY

Principal Investigators

  • Tapio Aalto, MD · Mehiläinen hospital

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-08
Primary Completion
2020-01-29
Completion
2020-01-29

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04161079 on ClinicalTrials.gov