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

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05986396
• Collaborator: Edwards Lifesciences (Industry)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 35.9
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Valve Prosthesis	Device: INSPIRIS Resilia (model 11500A)

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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve for Pulmonary Valve Replacement in Children and Young Adults
• Actual Study Start Date: Jan 3, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
All Subjects Subjects that have received the INSPIRIS Resilia device.	Device: INSPIRIS Resilia (model 11500A); Aortic Valve

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine at CHRISTUS Children's	San Antonio	Texas	United States	78207

Sponsors and Collaborators

• Baylor College of Medicine
• Edwards Lifesciences

Investigators

• Principal Investigator: Victor Bautista-Hernandez, MD, PhD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Victor Bautista Hernandez, Associate Professor of Surgery, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT05986396
• Other Study ID Numbers: H-51357
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Victor Bautista Hernandez, Associate Professor of Surgery, Baylor College of Medicine: Pulmonary Valve Replacement; Pulmonary Valve; Congenital Heart Disease; INSPIRIS Resilia

Study Results

No Results Posted as of Aug 14, 2023