NCT05583656

INSPIRIS RESILIA Valve in Pulmonary Position

INSPIRIS RESILIA Valve in Pulmonary Position - A Prospective Clinical Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 5 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

In this trial we intend to evaluate the safety and effectiveness of the INSPIRIS valve prothesis in the pulmonary position in patients of five years or older, with congenital or acquired pulmonary valve disease, requiring replacement of their native or prosthetic pulmonary valve.

Detailed description

Up to 40 subjects will be invited to participate in this trial after the indication for pulmonary valve replacement has been established. At the inclusion visit, patients will be screened according to the inclusion / exclusion criteria. After written informed consent, a detailed history will be obtained, and the study related exams will be performed. The procedure will be performed through a median sternotomy with the help of cardiopulmonary bypass in a beating or arrested heart fashion depending on the individual surgeon's discretion. Any additional or residual defects will concomitantly be addressed. Either a native or prosthetic pulmonary valve will be replaced by an Edwards Inspiris valve (Edwards Lifesciences, Unterschleissheim, Germany). If a conduit is required, the valve will be sewn into a suitable prosthesis beforehand. Subjects will be seen regularly after pulmonary valve implantation at hospital discharge, 6-month, 1 year and 2 years after surgery. A cardiac magnetic resonance imaging will be performed at inclusion and 2 years after surgery. Total enrollment period for the study is estimated to be two years. The trial starts with the enrollment of the first patients and ends after the last patient enrolled has completed the two-year visit or has exited the study.

Conditions

• Pulmonary Valve Disorder
• Congenital Heart Disease

Interventions

Type	Name	Description
PROCEDURE	Pulmonary valve replacement	Surgical replacement of the pulmonary valve using the Edwards Inspiris Resilia prosthesis.

Timeline

• Start date: 2019-08-12
• Primary completion: 2023-08-01
• Completion: 2024-02-01
• First posted: 2022-10-18
• Last updated: 2022-10-18

Locations

1 site across 1 country: Austria