Long Term Surveillance of Patients with Right ventricular outflow tract dysfunction treated by surgical conduit implantation versus percutaneous pulmonary valve implantation with Melody Valve

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010273

Enrollment

400

Registered

2016-04-14

Start date

2014-08-01

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

I37.0 I37.1

Interventions

Group 1: Follow up of patients with right ventricular outflow tract dysfunction treated by a percutaneuous pulmonary valve implantation with the melody valve. be observed by Echo data: LVOT gradient a

Eligibility

Sex/Gender

All

Age

5 Years to 90 Years

Inclusion criteria

Inclusion criteria: All patients >= 5 years who received either a percutaneous Melody valve or a biological conduit for RVOT dysfunction at the German Heart Centre Munich since 2006 -Patient informed consent / data release form

Exclusion criteria

Exclusion criteria: Patients < 5 years of age Previous percutaneous valve implantation No Patient informed consent

Design outcomes

Primary

Measure	Time frame
conduit survival defined as time to explant, re-intervention or re-operation Observation period at least 2 years	—

Secondary

Measure	Time frame
death, endocarditis, structural conduit dysfunction Observation period at least 2 years The dysfunction is charged by data Echo	—

Countries

Germany

Contacts

Public ContactAndreas Eicken

Deutsches Herzzentrum München Klinik für Kinderkardiologie und angeborene Herzfehler

eicken@dhm.mhn.de+498912182332

Outcome results

None listed

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