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The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
Subjects will be followed-up through 6 weeks post implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intevention-PMVr Procedure | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr) | Device | A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device and Procedural Success | The primary objective is to evaluate the technical feasibility and acute device deployment characteristics of the SJM PMVr Device. Technical feasibility and deployment characteristics will be defined as:
| During the investigational procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of SAEs reported that are unique to the investigational procedure | The secondary objective is to evaluate safety of the SJM PMVr device by summarizing SAEs unique to accessing the valve, placing the clip, and removing the delivery system. | Through 6 weeks post-implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papworth Hospital | Cambridge | United Kingdom |
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| ID | Term |
|---|---|
| D008945 | Mitral Valve Prolapse |
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D016127 | Heart Valve Prolapse |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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