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Completed

NCT Number: NCT00567853

Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair

The purpose of this study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair.

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Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is 18 years old or older
  • An annuloplasty ring is indicated for reinforcement of a dysfunctional or diseased native mitral valve according to the current medical practice for valvular repair at each site.
  • The subject is able to return for all follow-up evaluations of the study.

Exclusion criteria

  • The subject or subject's legal representative is unwilling to sign the informed consent.
  • The subject is or will be participating in another medical device or drug clinical trial.
  • The subject is a minor, prisoner, institutionalized, or is unable to give informed consent.
  • The subject has a life expectance of less than 1 year.

Treatment and study plan

Implantation of the MEMO 3D Annuloplasty Ring

Device

Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.

Primary outcomes

  1. The percentage of patients with successful repair at 6 months.

    Time frame: One Year

Secondary outcomes

  1. Freedom from re-operation at 12 months. Preoperative and postoperative mitral valve regurgitation and LV dimensions and mass assessed by echocardiography. Actuarial survival and freedom from clinical events at 12 months.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Sorin Group USA, Inc.

Industry

Registry information

Official study title

Clinical Investigation Of The Sorin 3D Annuloplasty Ring For Mitral Repair

Acronym: MEMO3D

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2007
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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