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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

Recruiting
64 years and younger
All
Phase N/A
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Overview

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.

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.

Eligibility

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.

Study details
    Heart Valve Prosthesis

NCT05986396

Baylor College of Medicine

28 January 2024

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