RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve for Pulmonary Valve Replacement in Children and Young Adults

Quick Facts

Study Start:2023-01-03
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05986396

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Rosario Ocampo, BSN
CONTACT
210-704-4996
rosario.ocampo@christushealth.org

Principal Investigator

Victor Bautista-Hernandez, MD, PhD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Baylor College of Medicine at CHRISTUS Children's
San Antonio, Texas, 78207
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Victor Bautista-Hernandez, MD, PhD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-03
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-01-03
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Heart Valve Prosthesis