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CorAssist believes that certain improvements are needed to the device
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This study is designed to evaluate the ImCardia safety and to demonstrate system functionality in patients undergoing AV replacement with respect to 36 months follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ImCardia | Experimental | Aortic Stenosis patients candidates for Aortic Valve Replacement (AVR) implanted with the ImCardia device |
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| AVR control group | No Intervention | Aortic stenosis patients candidates for aortic valve replacement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ImCardia Device | Device | The device operates by harnessing energy expended by the left ventricle (LV) during Systole and returning it to the heart during Diastole thereby making it available to augment diastolic performance |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse event reporting | Adverse event reporting will continue up to 36 month follow up. Any complication attributed to the device will be recorded. Any Major Adverse Cardiac Event (MACE) will be evaluated in a safety committee composed from company representative and a cardiosurgeon which is not part of the company | 36 month |
| Measure | Description | Time Frame |
|---|---|---|
| Functionality - Successful Device implantation | The surgeon will score device implantation procedure post operation. | Immediately post implantation day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lea Lak, M.D. | CorAssist Cardiovascular | Study Director |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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