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

Mitral Valve Regurgitation Clinical Trial

— MEMO3D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567853
• Other study ID #: MEMO3D.Reg
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2007
• Last updated: January 22, 2015
• Start date: August 2007
• Est. completion date: June 2013

Study information

• Verified date: January 2015
• Source: Sorin Group USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• Implantation of the MEMO 3D Annuloplasty Ring
Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	University of Pennsylvania Presbyterian Hospital	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Barnes Jewish Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Sorin Group USA, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients with successful repair at 6 months.		One Year	Yes
Secondary	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.		12 months	Yes