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This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. The primary objective of the study is to demonstrate the effectiveness of the SJM® Rigid Saddle Ring when used in mitral valve repair procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SJM® Rigid Saddle Ring | Other | The SJM® Rigid Saddle Ring is an annuloplasty ring comprised of a titanium core surrounded by a double-velour, polyester fabric sewing cuff. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mitral valve repair (SJM® Rigid Saddle Ring) | Device | mitral valve repair due to mitral degenerative or functional disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative). | 6 months | |
| NYHA class | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events rates | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raffaele De Simone, Prof. Dr. | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Heidelberg | Heidelberg | 69120 | Germany |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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