Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT05583656
Brief 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.
Study:
NCT05583656
Study Brief:
Protocol Section:
NCT05583656