Congenital Heart Disease (CHD)NCT06845371
MELODY Registry Follow-Up Study
An observational study of Congenital Heart Disease (CHD), run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Extension of the MELODY Registry, to assess longterm follow-up clinical results of Melody valve implantation after its commercialization in Europe / OUS Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease (CHD)
- How many people
- 845 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2026to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent Melody valve implantation into the pulmonary position after its commercialization in Europe / OUS
Who may be able to join
- previous inclusion in the MELODY Registry
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tübingen
Tübingen
Johannes Nordmeyer, +49 (0) 7071 29-84751, johannes.nordmeyer@med.uni-tuebingen.de
About this study
Extension of the MELODY Registry, to assess longterm follow-up clinical results of Melody valve implantation after its commercialization in Europe / OUS
- Conditions
- Congenital Heart Disease (CHD)
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome
- composite endpoint of TPVI related follow-up events (i.e. death, reoperation, or reintervention >48h after TPVI)
Measured: from december 2006 up to December 2027
Secondary outcomes (1)
secondary measure
TPVI infective endocarditis (I.E.) according to modified Duke criteria n
Measured: from december 2006 up to December 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Apr 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 845 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845371
- Sponsor's protocol ID
- Melody
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MELODY Registry Follow-Up Study
- ClinicalTrials.gov ID
- NCT06845371
- Acronym / sponsor ID
- Melody
- Conditions
- Congenital Heart Disease (CHD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 845 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Extension of the MELODY Registry, to assess longterm follow-up clinical results of Melody valve implantation after its commercialization in Europe / OUS
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent Melody valve implantation into the pulmonary position after its commercialization in Europe / OUS
Key inclusion criteria (1 listed)
- previous inclusion in the MELODY Registry
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
primary outcome
Time frame: from december 2006 up to December 2027
• composite endpoint of TPVI related follow-up events (i.e. death, reoperation, or reintervention >48h after TPVI)
1 secondary outcome
secondary measure
Time frame: from december 2006 up to December 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease (CHD), run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Nordmeyer, Prof (+49 (0) 7071 29-84751, Johannes.Nordmeyer@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome (time frame: from december 2006 up to December 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.