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Effect of percutaneous pulmonary valve replacement on biventricular intrinsic myocardial function in patients with RVOT dysfunction – a real-time pressure-volume loop study using conductance catheter technique

Effect of percutaneous pulmonary valve replacement on biventricular intrinsic myocardial function in patients with RVOT dysfunction – a real-time pressure-volume loop study using conductance catheter technique

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00020854
Enrollment
20
Registered
2020-02-25
Start date
2020-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Q20.8

Interventions

Group 1: 1) Quantification of biventricular intrinsic function during percutaneous pulmonary valve implantation procedure 2) Follow-up assessment of biventricular size and function 6 months after valv

Sponsors

Klinik für Kinderkardiologie und angeborene Herzfehler Deutsches Herzzentrum München Klinik an der Technischen Universität München
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Changes of intrinsic biventricular function in response to pulmonary valve replacement

Secondary

MeasureTime frame
Quantification of changes in biventricular size and function 6 months post valve implantation using CMR

Countries

Germany

Contacts

Public ContactHeiner Latus

Klinik für Kinderkardiologie und angeborene HerzfehlerDeutsches Herzzentrum München Klinik an der Technischen Universität München

latus@dhm.mhn.de089-1218-3011

Outcome results

None listed

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