MELODY Registry Follow-Up Study

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

Recruiting

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Key information

Conditions

Congenital Heart Disease (CHD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Tübingen

Tübingen, Germany

Location status: Recruiting

Location contact

Johannes Nordmeyer

CONTACT

[email protected]

+49 (0) 7071 29-84751

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

previous inclusion in the MELODY Registry

Exclusion criteria

none

Treatment and study plan

Primary outcomes

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)

Secondary outcomes

secondary measure

Time frame: from december 2006 up to December 2027

TPVI infective endocarditis (I.E.) according to modified Duke criteria n

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Nordmeyer, Prof

CONTACT

[email protected]

+49 (0) 7071 29-84751

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Feb 25, 2025
Registry last updated: May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting