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

Completed · Phase 3

Conditions studied: Mitral Valve Regurgitation

In brief

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.

Key facts

Study ID

NCT00567853

Run by

Sorin Group USA, Inc.

People needed

278

Starts

2007-08-01

Expected to finish

2013-06-01

Last updated by the study team

2015-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.