Long-Term Follow-Up Study of Melody Valve Implantation in Congenital Heart Disease Patients

What this Trial Is About

This research aims to assess the long-term clinical outcomes of the Melody valve implantation in patients with congenital heart disease. It extends the MELODY Registry to follow up on patients after the valves commercialization in Europe and other countries outside the United States. The study is observational and focuses on collecting ongoing data related to the valves performance over time. Participants have previously been included in the MELODY Registry following their Melody valve implantation. This follow-up study continues to observe these patients without introducing new treatments or interventions. The study spans from December 2006 up to August 2027, gathering comprehensive data over this extended period. Throughout the study, researchers will monitor the primary and secondary outcomes related to the Melody valves function and patient health. Data collection will occur at regular intervals, reflecting the patients clinical status and valve performance. The study does not involve additional treatments but focuses on long-term observation and documentation of results.

MELODY Registry Follow-Up Study