Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve for Pulmonary Valve Replacement in Children and Young Adults
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Valve Prosthesis
- Sponsor
- Baylor College of Medicine
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Contribute to the scarce body of literature
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Victor Bautista Hernandez
Associate Professor of Surgery
Baylor College of Medicine
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Contribute to the scarce body of literature
Time Frame: 5 years after implantation
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
Secondary Outcomes
- Identify the effect of age of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults(5 years after implantation)