MELODY Registry Follow-Up Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06845371

Enrollment

845

Registered

2025-02-25

Start date

2026-04-01

Completion date

2027-08-01

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease (CHD)

Brief summary

Extension of the MELODY Registry, to assess longterm follow-up clinical results of Melody valve implantation after its commercialization in Europe / OUS

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* previous inclusion in the MELODY Registry

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
primary outcome	from december 2006 up to December 2027	• composite endpoint of TPVI related follow-up events (i.e. death, reoperation, or reintervention \>48h after TPVI)

Secondary

Measure	Time frame	Description
secondary measure	from december 2006 up to December 2027	TPVI infective endocarditis (I.E.) according to modified Duke criteria n

Countries

Germany

Contacts

CONTACTJohannes Nordmeyer, Prof

Johannes.Nordmeyer@med.uni-tuebingen.de+49 (0) 7071 29-84751

Outcome results