Q20.8
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with RVOT dysfunction who undergo PPVI with a MelodyTM valve (Medtronic, Dublin, Ireland) in the catheterization laboratory. Current indications for PPVI at our centre are: RVOT obstruction with or without pulmonary regurgitation and - tricuspid regurgitation jet velocity >3.5 m/s in the presence of symptoms or decreased physical capacity (4.3 m/s or more than twothirds systemic RV pressure without symptoms - severe pulmonary regurgitation with progressive RV dilatation with indexed RVEDV >150 ml/m2 and/or declining RV function
Exclusion criteria
Exclusion criteria: - Implantation of a transcatheter pulmonary valve other than the MelodyTM valve - Body weight <20 kg - Anatomic or hemodynamic difficulty to place the conductance catheter in the RV/LV - Any other disorders that disables the patient to take part in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of intrinsic biventricular function in response to pulmonary valve replacement | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantification of changes in biventricular size and function 6 months post valve implantation using CMR | — |
Countries
Germany
Contacts
Klinik für Kinderkardiologie und angeborene HerzfehlerDeutsches Herzzentrum München Klinik an der Technischen Universität München