Recruiting

INSPIRIS Valve

Sponsor:

Baylor College of Medicine

Code:

NCT05986396

Conditions

Heart Valve Prosthesis

Eligibility Criteria

Sex: All

Age: 0 - 64

Healthy Volunteers: Not accepted

Interventions

INSPIRIS Resilia (model 11500A)

Study Details

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.

Conditions

Heart Valve Prosthesis

Study ID

NCT05986396

Start date

Jan 3, 2023

Status verified date

Aug, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 64

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

All Subjects

Subjects that have received the INSPIRIS Resilia device.

Interventions

INSPIRIS Resilia (model 11500A)

Aortic Valve

Primary outcome measure

  • Contribute to the scarce body of literature [ Time Frame: 5 years after implantation ]

Central Contacts and Locations

Central contacts

Rosario Ocampo, BSN

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

Locations

Baylor College of Medicine at CHRISTUS Children's

Recruiting

San Antonio, Texas, United States, 78207

Contacts

Rosario Ocampo, BSN

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

More Information

Sponsor

Baylor College of Medicine

Last update posted

Aug 14, 2023

Last verified

Aug, 2023

Keywords

  • Pulmonary Valve Replacement
  • Pulmonary Valve
  • Congenital Heart Disease
  • INSPIRIS Resilia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2023-08-14.