Clinical trial Recruiting at 1 site Observational

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 typeObservational
SexAll
Enrollment845 (estimated)
SponsorUniversity Hospital Tuebingen
Academic / other
Locations1 site (Tübingen)
StatusRecruiting
StartedApril 1, 2026
Main results expectedMay 1, 2027
Study endsAugust 1, 2027
Registry record updatedMay 4, 2026
Trial IDNCT06845371 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.