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To demonstrate that the Conveyor System can safely provide left ventricular access to deliver the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients who have been diagnosed with prior mitral valve replacement or repair (failing bioprosthetic mitral valve) who are candidates for mitral valve-in-valve procedure.
This is a prospective, non-randomized, multi-center early feasibility study designed to demonstrate that the Conveyor System can safely provide left ventricular access to deliver an Edwards SAPIEN 3 TAVR valve into the mitral valve position in a valve-in-valve procedure. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed insufficient, or combined).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Arm | Experimental | Access, delivery, and retrieval of the Conveyor system with correct positioning of the valve delivery system to facilitate correct positioning of the implant at the mitral location in patients with a failing bioprosthetic valve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitral valve-in-valve | Device | The Synecor Conveyor System shall be used to position the Edwards SAPIEN 3 valve at the mitral location. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correct Positioning of Implant | The ability of the Conveyor System to safely position the valve delivery system to facilitate correct positioning of the implant without causing any serious adverse events through 30-day follow up. Cineangiography will be used in delivery to ensure that the implant is orthogonal to the mitral valve annulus and centered within it from multiple views. The patient will be seen in the clinic in a routine follow-up to ascertain any untoward clinical signs or symptoms. | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Baker, PhD | Contact | 9787643434 | lbaker@boston-biomedical.com |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
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Device: Synecor Conveyor System
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