Evaluating the outcomes of the INSPIRIS pulmonary valve in children and young adults
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve for Pulmonary Valve Replacement in Children and Young Adults
This study looks at how well the INSPIRIS pulmonary valve works in children and young adults over time to see if it lasts and keeps them healthy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 0 Years to 64 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT05986396 on ClinicalTrials.gov |
What this trial studies
This observational study conducts a retrospective chart review to assess the mid-term durability and hemodynamics of the INSPIRIS Resilia bioprosthesis in children and young adults. The primary objective is to analyze various factors such as the effect of age on structural valve deterioration (SVD), freedom from SVD, valve-related complications, and overall survival rates. By examining data from patients who received the valve between June 2017 and December 2022, the study aims to fill gaps in the existing literature regarding this specific valve's performance in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates for this study are children and young adults who have received the INSPIRIS Resilia valve.
Not a fit: Patients who have not received the INSPIRIS Resilia device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the INSPIRIS Resilia valve for young patients with congenital heart disease.
How similar studies have performed: While there is limited literature on the INSPIRIS Resilia valve specifically, similar studies on bioprosthetic valves in pediatric populations have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Antonio, Texas
- Baylor College of Medicine at CHRISTUS Children's — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Victor Bautista-Hernandez, MD, PhD — Baylor College of Medicine
- Study coordinator: Rosario Ocampo, BSN
- Email: rosario.ocampo@christushealth.org
- Phone: 210-704-4996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.