Symphony Registry - Melody® Best Practice Study

Symphony Registry - Melody® Best Practice Study - Symphony Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029732

Enrollment

150

Registered

2022-10-20

Start date

2023-05-25

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Tetralogy of Fallot with pulmonary stenosis or pulmonary atresia or absent pulmonary valve Transposition of the Great ArteriesTruncus ArteriosusAortic Valve deseaseIsolated Pulmonary stenosiswith: predominant ore pure regurgitationMixed stenotic and regurgitation orpredominant or pure stenosiswith indication for valve replacement with a Melody valve

Interventions

Group 1: Observation group: After successful Melody® valve implantation under Best Practice Conditions, the patient and/or the legal representatives are informed about the clinical study by an invest

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 12 years and older 2. Successful implantation of a Melody® valve under Best Practice conditions 3. Residual peak to peak gradient across the new implanted Melody® valve must not exceed 15mmHg measured invasively. 4. Follow up treatment and surveillance planned according to Best Practice 5. Patient who is willing to complete the Follow up Visits in the treating hospital 6. Informed consent by patient and/or legal representatives

Exclusion criteria

Exclusion criteria: 1. Landing zone after pre-stenting less than 22 mm diameter 2. Severe immune deficiency (e.g. di George) 3. Significant immunosuppressive medication 4. History of Endocarditis 5. actual dental infection (dental report not older than three months ) 6. Actual infectious skin diseases

Design outcomes

Primary

Measure	Time frame
Freedom from valve explantation after 5 years follow up	—

Secondary

Measure	Time frame
Freedom from transcatheter re-intervention due to valve dysfunction Freedom from valve-in-valve implantation Freedom from RVOT mean gradient > 30mmHg, measured by Echo Freedom from moderate to severe regurgitation, measured in MRI Freedom from endocarditis of the Melody valve	—

Countries

Austria, France, Germany, Italy, Switzerland

Contacts

Public ContactAndrea Engelhardt

Deutsches Herzzentrum München TUM Universitätsklinikum Klinik für angeborene Herzfehler und Kinderkardiologie, Studienzentrum

PM.Symphony@dhm.mhn.de+498912181658

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026