Long-term follow-up after Melody heart valve placement
MELODY Registry Follow-Up Study
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 |
|---|---|
| Enrollment | 845 (estimated) |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT06845371 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous registries and trials have shown mid-term effectiveness and safety of the Melody valve, but comprehensive long-term post-commercialization data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * previous inclusion in the MELODY Registry Exclusion Criteria: * none
Where this trial is running
Tübingen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.