Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair
This trial is active, not recruiting.
|Condition||mitral valve regurgitation|
|Treatment||implantation of the memo 3d annuloplasty ring|
|Sponsor||Sorin Group USA, Inc.|
|Start date||August 2007|
|End date||June 2013|
|Trial size||200 participants|
|Trial identifier||NCT00567853, MEMO3D.Reg|
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|
|Minneapolis, MN||Minneapolis Heart Institute||no longer recruiting|
|St. Louis, MO||Barnes Jewish Hospital||no longer recruiting|
|Philadelphia, PA||University of Pennsylvania Presbyterian Hospital||no longer recruiting|
|Plano, TX||The Heart Hospital Baylor Plano||no longer recruiting|
|Calgary, Canada||Foothills Medical Centre||no longer recruiting|
|Halifax, Canada||Queen Elizabeth II Health Sciences Centre||no longer recruiting|
|Intervention model||single group assignment|
All patients in the study will be implanted with the MEMO 3D ring
The percentage of patients with successful repair at 6 months.
time frame: One Year
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
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.
|Official title||Clinical Investigation Of The Sorin 3D Annuloplasty Ring For Mitral Repair|
|Principal investigator||Clark Hargrove, M.D.|
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