RECRUITING
I'm interested ...!!
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve
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 Start (Actual) 3 January 2023
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 100
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 San Antonio, Texas, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 0 Years to 64 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 12 July 2023
  • First Submitted that Met QC Criteria 1 August 2023
  • First Posted 14 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 August 2023
  • Last Update Posted 14 August 2023
  • Last Verified August 2023
I'm interested ...!!