NCT05986396

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

July 12, 2023

Last Update Submit

August 1, 2023

Conditions

Heart Valve Prosthesis

Keywords

Pulmonary Valve ReplacementPulmonary ValveCongenital Heart DiseaseINSPIRIS Resilia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (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

Study Arms (1)

All Subjects

Subjects that have received the INSPIRIS Resilia device.

Device: INSPIRIS Resilia (model 11500A)

Interventions

INSPIRIS Resilia (model 11500A)DEVICE

Aortic Valve

All Subjects

Eligibility Criteria

Age0 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects with congenital heart disease that have received the INSPIRIS Resilia device.

You may qualify if:

  • Subjects that have received the INSPIRIS Resilia device at participating institutions from 06/2017 through 12/2022.

You may not qualify if:

  • Subjects that have not received the INSPIRIS Resilia device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine at CHRISTUS Children's

San Antonio, Texas, 78207, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Victor Bautista-Hernandez, MD, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosario Ocampo, BSN

CONTACT

210-704-4996rosario.ocampo@christushealth.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

July 12, 2023

First Posted

August 14, 2023

Study Start

January 3, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)