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

Sorin Group USA, Inc.6 sites in 2 countries278 target enrollmentAugust 2007

ConditionsMitral Valve Regurgitation

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Mitral Valve Regurgitation
Sponsor: Sorin Group USA, Inc.
Enrollment: 278
Locations: 6
Primary Endpoint: The percentage of patients with successful repair at 6 months.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

June 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sorin Group USA, Inc.

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

The percentage of patients with successful repair at 6 months.

Time Frame: One Year

Secondary Outcomes

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)