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

Phase 3

Completed

• Conditions: Mitral Valve Regurgitation
• Interventions: Device: Implantation of the MEMO 3D Annuloplasty Ring

• Registration Number: NCT00567853
• Lead Sponsor: Sorin Group USA, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-22
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MEMO 3D ring	Implantation of the MEMO 3D Annuloplasty Ring	All patients in the study will be implanted with the MEMO 3D ring

Primary Outcome Measures

Name	Time	Method
The percentage of patients with successful repair at 6 months.	One Year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

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

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada