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A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a minimally invasive trans-catheter method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMEND | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMEND Mitral Valve Repair System | Device | Annuloplasty ring applied in a transcatheter method |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Freedom from major SAE's at 30 days following procedure | Freedom from major SAE's at 30 days following procedure | 30 days |
| Technical success of implantation | Ring location and attachment based on echocardiography | End of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Freedom from major SAE's at 6 months following procedure | Freedom from major SAE's at 6 months following procedure | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Middelheim Hospital | Antwerp | 2020 | Belgium | |||
| Na Homolce Hospital |
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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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| Prague |
| 15030 |
| Czechia |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Azienda Ospedaliera Di Padova | Padova | Italy |