MELODY Registry Follow-Up Study

Not yet recruiting

• Conditions: Congenital Heart Disease (CHD)

• Registration Number: NCT06845371
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Study Start: 2025-05-01
• Primary Completion: 2027-05-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 845

Inclusion Criteria

• previous inclusion in the MELODY Registry

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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