Long-term follow-up after Melody heart valve placement
Official title: MELODY Registry Follow-Up Study
Run by University Hospital Tuebingen · NCT06845371 · Data updated 2026-11-12
This follow-up will see how people with congenital heart disease who previously received a Melody valve are doing over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 845 (estimated) |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | May 1, 2027 |
| Study ends | August 1, 2027 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT06845371 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with congenital heart disease who were previously included in the original MELODY Registry and are willing to provide follow-up information.
✕Probably not a fit
Patients who never had a Melody valve implanted or who were not part of the original registry are not eligible and would not directly benefit from this follow-up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This registry extension collects long-term clinical follow-up data on patients with congenital heart disease who previously received a Melody transcatheter pulmonary valve as part of the original MELODY Registry. It is purely observational with no new interventions; investigators will record outcomes such as valve durability, reinterventions, complications, and survival from routine care and follow-up visits. Enrollment is limited to participants from the original registry and data are captured at University Hospital Tübingen or via arranged remote reporting. The project aims to describe real-world long-term device performance after commercialization in Europe and other outside-US markets.
Why it matters
Potential benefit: If successful, this work could clarify the long-term safety and durability of the Melody valve, helping clinicians and patients make better-informed treatment choices.
How similar studies have gone: Previous registries and trials have shown mid-term effectiveness and safety of the Melody valve, but comprehensive long-term post-commercialization data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * previous inclusion in the MELODY Registry Exclusion Criteria: * none
Where it's running
-
University Hospital Tübingen
Tübingen, Germany Recruiting
Study contacts
- Study coordinator: Johannes Nordmeyer, Prof
- Email: Johannes.Nordmeyer@med.uni-tuebingen.de
- Phone: +49 (0) 7071 29-84751
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.