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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05986396
Enrollment
100
Registered
2023-08-14
Start date
2023-01-03
Completion date
2025-12-31
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Prosthesis

Keywords

Pulmonary Valve Replacement, Pulmonary Valve, Congenital Heart Disease, INSPIRIS Resilia

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.

Interventions

DEVICEINSPIRIS Resilia (model 11500A)

Aortic Valve

Sponsors

Edwards Lifesciences
CollaboratorINDUSTRY
Baylor College of Medicine
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 64 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Contribute to the scarce body of literature5 years after implantationThe 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

MeasureTime frameDescription
Identify the effect of age of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults5 years after implantationStructural valve deterioration, freedom from SVD, valve related complications, freedom from re-operation, survival rate

Countries

United States

Contacts

Primary ContactRosario Ocampo, BSN
rosario.ocampo@christushealth.org210-704-4996

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026