Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair
Phase 3
Completed
- Conditions
- Mitral Valve Regurgitation
- 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
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
- 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)
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
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Minneapolis Heart Institute🇺🇸Minneapolis, Minnesota, United States