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

Primary Purpose

Mitral Valve Regurgitation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Implantation of the MEMO 3D Annuloplasty Ring
Sponsored by
Sorin Group USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring mitral valve regurgitation, mitral valve disease, mitral valve repair, mitral valve dysfunction, heart valve, valve disease, cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Minneapolis Heart Institute
  • Barnes Jewish Hospital
  • University of Pennsylvania Presbyterian Hospital
  • The Heart Hospital Baylor Plano
  • Foothills Medical Centre
  • Queen Elizabeth II Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MEMO 3D ring

Arm Description

All patients in the study will be implanted with the MEMO 3D ring

Outcomes

Primary Outcome Measures

The percentage of patients with successful repair at 6 months.

Secondary Outcome Measures

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.

Full Information

First Posted
December 4, 2007
Last Updated
January 22, 2015
Sponsor
Sorin Group USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00567853
Brief Title
Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair
Acronym
MEMO3D
Official Title
Clinical Investigation Of The Sorin 3D Annuloplasty Ring For Mitral Repair
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorin Group USA, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation
Keywords
mitral valve regurgitation, mitral valve disease, mitral valve repair, mitral valve dysfunction, heart valve, valve disease, cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEMO 3D ring
Arm Type
Other
Arm Description
All patients in the study will be implanted with the MEMO 3D ring
Intervention Type
Device
Intervention Name(s)
Implantation of the MEMO 3D Annuloplasty Ring
Intervention Description
Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.
Primary Outcome Measure Information:
Title
The percentage of patients with successful repair at 6 months.
Time Frame
One Year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clark Hargrove, M.D.
Organizational Affiliation
University of Pennsylvania Presbyterian Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Barnes Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63100
Country
United States
Facility Name
University of Pennsylvania Presbyterian Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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