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The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portico Implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portico Transapical Aortic Valve System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Event rates |
| 30 days |
| Functional improvements from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Walther, MD, PhD | Kerckhoff Klinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital | London | United Kingdom |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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|
| 30 days |
| Acute device success |
| At time of procedure |