Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve

Heart Valve Prosthesis Clinical Trial

Official title:

Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve for Pulmonary Valve Replacement in Children and Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986396
• Other study ID #: H-51357
• Status: Recruiting
• Start date: January 3, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Baylor College of Medicine
• Contact: Rosario Ocampo, BSN
• Phone: 210-704-4996
• Email: rosario.ocampo[@]christushealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 64 Years

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.

Related Conditions & MeSH terms

• Heart Valve Prosthesis

Intervention

Device:
• INSPIRIS Resilia (model 11500A)
Aortic Valve

Locations

Country	Name	City	State
United States	Baylor College of Medicine at CHRISTUS Children's	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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