Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair (MEMO3D)
This study is ongoing, but not recruiting participants.
Sponsor:
Sorin Group USA, Inc.
Information provided by (Responsible Party):
Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:
NCT00567853
First received: December 4, 2007
Last updated: March 7, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mitral Valve Regurgitation |
Device: Implantation of the MEMO 3D Annuloplasty Ring |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Investigation Of The Sorin 3D Annuloplasty Ring For Mitral Repair |
Further study details as provided by Sorin Group USA, Inc.:
Primary Outcome Measures:
- The percentage of patients with successful repair at 6 months. [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
MEMO 3D ring
All patients in the study will be implanted with the MEMO 3D ring
|
Device: Implantation of the MEMO 3D Annuloplasty Ring
Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567853
Locations
| United States, Minnesota | |
| Minneapolis Heart Institute | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Missouri | |
| Barnes Jewish Hospital | |
| St. Louis, Missouri, United States, 63100 | |
| United States, Pennsylvania | |
| University of Pennsylvania Presbyterian Hospital | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| The Heart Hospital Baylor Plano | |
| Plano, Texas, United States, 75093 | |
| Canada, Alberta | |
| Foothills Medical Centre | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
Sponsors and Collaborators
Sorin Group USA, Inc.
Investigators
| Principal Investigator: | Clark Hargrove, M.D. | University of Pennsylvania Presbyterian Medical Center |
More Information
No publications provided
| Responsible Party: | Sorin Group USA, Inc. |
| ClinicalTrials.gov Identifier: | NCT00567853 History of Changes |
| Other Study ID Numbers: | MEMO3D.Reg |
| Study First Received: | December 4, 2007 |
| Last Updated: | March 7, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Sorin Group USA, Inc.:
|
mitral valve regurgitation mitral valve disease mitral valve repair mitral valve dysfunction |
heart valve valve disease cardiac surgery |
Additional relevant MeSH terms:
|
Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013