Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair (MEMO3D)

January 22, 2015 updated by: Sorin Group USA, Inc.

Clinical Investigation 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elizabeth II Health Sciences Centre
  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
    • Missouri
      • St. Louis, Missouri, United States, 63100
        • Barnes Jewish Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Presbyterian Hospital
    • Texas
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MEMO 3D ring
All patients in the study will be implanted with the MEMO 3D ring
Device: Implantation of the MEMO 3D Annuloplasty Ring
Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of patients with successful repair at 6 months.
Time Frame: One Year
One Year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorin Group USA, Inc.

Investigators

  • Principal Investigator: Clark Hargrove, M.D., University of Pennsylvania Presbyterian Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimate)

December 5, 2007

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEMO3D.Reg

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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