Trials / Unknown
UnknownNCT05986396
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve for Pulmonary Valve Replacement in Children and Young Adults
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Baylor College of Medicine · Academic / Other
- Sex
- All
- Age
- 0 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | INSPIRIS Resilia (model 11500A) | Aortic Valve |
Timeline
- Start date
- 2023-01-03
- Primary completion
- 2024-12-31
- Completion
- 2025-12-31
- First posted
- 2023-08-14
- Last updated
- 2023-08-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05986396. Inclusion in this directory is not an endorsement.