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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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The goal of this retrospective chart review is to contribute to the literature on the mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in children and young adults.
The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults. Investigators also aim to identify: effect of age on SVD, freedom from SVD, pathology of SVD, valve-related complications, freedom from re-operation, and survival rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | Subjects that have received the INSPIRIS Resilia device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INSPIRIS Resilia (model 11500A) | Device | Aortic Valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contribute to the scarce body of literature | The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults | 5 years after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the effect of age of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults | Structural valve deterioration, freedom from SVD, valve related complications, freedom from re-operation, survival rate | 5 years after implantation |
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Inclusion Criteria:
Subjects that have received the INSPIRIS Resilia device at participating institutions from 06/2017 through 12/2022.
Exclusion Criteria:
Subjects that have not received the INSPIRIS Resilia device.
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Subjects with congenital heart disease that have received the INSPIRIS Resilia device.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosario Ocampo, BSN | Contact | 210-704-4996 | rosario.ocampo@christushealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Victor Bautista-Hernandez, MD, PhD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine at CHRISTUS Children's | Recruiting | San Antonio | Texas | 78207 | United States |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |