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The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
The EFS will evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BE TAVI System | Experimental | BE TAVI System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbott BE TAVI System | Device | Abbott BE TAVI System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system. | From start of procedure up to end of procedure |
| Device success | Intended performance of the valve | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashish Oza | Abbott Structural Heart | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States | ||
| Abbott Northwestern Hospital |
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| Minneapolis |
| Minnesota |
| 55407 |
| United States |
| Columbia University Medical Center/New York-Presbyterian | New York | New York | 10032 | United States |
| Montefiore Medical Center - Moses Division | The Bronx | New York | 10461 | United States |
| Clinique Pasteur Toulouse | Toulouse | Midpyre | 31076 | France |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D014694 | Ventricular Outflow Obstruction |
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