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Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation

NCT01678144 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-08-09

Study results available
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Summary

The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial aims to demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty rings.

Conditions

  • Mitral Regurgitation
  • Mitral Insufficiency

Interventions

DEVICE

Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)

Sponsors & Collaborators

  • Medtentia International Ltd Oy

    lead INDUSTRY

Principal Investigators

  • Kalervo Werkkala, M.D., Prof. · Helsinki University Central Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-07-30
Completion
2016-04-22

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 NCT01678144 on ClinicalTrials.gov