NCT06845371

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
845

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Aug 2027

First Submitted

Initial submission to the registry

February 7, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

February 7, 2025

Last Update Submit

April 28, 2026

Conditions

Congenital Heart Disease (CHD)

Outcome Measures

Primary Outcomes (1)

  • primary outcome

    • composite endpoint of TPVI related follow-up events (i.e. death, reoperation, or reintervention \>48h after TPVI)

    from december 2006 up to December 2027

Secondary Outcomes (1)

  • secondary measure

    from december 2006 up to December 2027

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent Melody valve implantation into the pulmonary position after its commercialization in Europe / OUS

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tübingen

Tübingen, Germany

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Johannes Nordmeyer, Prof

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 25, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

DE(1)