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This is a prospective, single arm feasibility study to establish safety and performance of the PAS-C System in subjects with heart failure and elevated left atrial pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InterShunt PAS-C | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAS-C System | Device | The InterShunt PAS-C System is a transcatheter system that creates a shunt by excising tissue from the interatrial septum resulting in a left to right atrial shunt that off-loads elevated left atrial pressure, potentially reducing symptoms and improving quality of life. The PAS-C System does not require a permanent implant to maintain patency of the interatrial shunt. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization. | The proportion of subjects who experience a composite MACCE or systemic embolization event. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiogram evidence of interatrial shunt with left to right atrial flow | Proportion of subjects with visible shunt demonstrating left to right atrial flow as determined by echocardiographer | 1 month |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tbilisi Heart and Vascular Clinic | Tbilisi | Georgia |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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