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

NCT05986396 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-08-14

No results posted yet for this study

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

Interventions

DEVICE

INSPIRIS Resilia (model 11500A)

Aortic Valve

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY
  • Baylor College of Medicine

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
0 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05986396 on ClinicalTrials.gov