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

Recruiting

• Conditions: Heart Valve Prosthesis
• Interventions: Device: INSPIRIS Resilia (model 11500A)

• Registration Number: NCT05986396
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study Start: 2023-01-03
• Study First Submitted: 2023-07-12
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Subjects	INSPIRIS Resilia (model 11500A)	Subjects that have received the INSPIRIS Resilia device.

Primary Outcome Measures

Name	Time	Method
Contribute to the scarce body of literature	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 Outcome Measures

Name	Time	Method
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	Structural valve deterioration, freedom from SVD, valve related complications, freedom from re-operation, survival rate

Trial Locations

Locations (1)

Baylor College of Medicine at CHRISTUS Children's; 🇺🇸 San Antonio, Texas, United States