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

Sorin

Status and phase: Completed; Phase 3

Conditions: Mitral Valve Regurgitation

Treatments: Device: Implantation of the MEMO 3D Annuloplasty Ring

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567853

MEMO3D.Reg

Details and patient eligibility

About

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.

Enrollment: 278 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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278 participants in 1 patient group

MEMO 3D ring

Other group

Description:

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

Treatment:

Device: Implantation of the MEMO 3D Annuloplasty Ring