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

Recruiting

• Conditions: I37.0; I37.1; Pulmonary valve stenosis; Pulmonary valve insufficiency

• Registration Number: DRKS00010273
• Lead Sponsor: Deutsches Herzzentrum München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 400

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

Patients < 5 years of age

Previous percutaneous valve implantation

No Patient informed consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
conduit survival defined as time to explant, re-intervention or re-operation<br>Observation period at least 2 years

Secondary Outcome Measures

Name	Time	Method
death, endocarditis, structural conduit dysfunction<br>Observation period at least 2 years <br>The dysfunction is charged by data Echo