Actively Recruiting
MELODY Registry Follow-Up Study
Led by University Hospital Tuebingen · Updated on 2026-05-04
845
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
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 valve's commercialization in Europe and other countries outside the United States. The study is observational and focuses on collecting ongoing data related to the valve's 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 valve's 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.
CONDITIONS
Brief Title
MELODY Registry Follow-Up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previous inclusion in the MELODY Registry
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From December 2006 up to August 2027
Participants are observed over time to collect outcome measures without receiving any intervention.
Visits as scheduled throughout the study period
Trial Site Locations
Total: 1 location
1
University Hospital Tübingen
Tübingen, Germany
Actively Recruiting
Research Team
J
Johannes Nordmeyer, Prof
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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