Overview

This trial is active, not recruiting.

Condition mitral valve regurgitation
Treatment implantation of the memo 3d annuloplasty ring
Phase phase 3
Sponsor Sorin Group USA, Inc.
Start date August 2007
End date June 2013
Trial size 200 participants
Trial identifier NCT00567853, MEMO3D.Reg

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
All patients in the study will be implanted with the MEMO 3D ring
implantation of the memo 3d annuloplasty ring
Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.

Primary Outcomes

Measure
The percentage of patients with successful repair at 6 months.
time frame: One Year

Secondary Outcomes

Measure
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.
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Clinical Investigation Of The Sorin 3D Annuloplasty Ring For Mitral Repair
Principal investigator Clark Hargrove, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Sorin Group USA, Inc..