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

Recruiting

• Conditions: Q20.8; Other congenital malformations of cardiac chambers and connections

• Registration Number: DRKS00020854
• Lead Sponsor: Klinik für Kinderkardiologie und angeborene Herzfehler Deutsches Herzzentrum München Klinik an der Technischen Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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 (<65% of the norm)
- tricuspid regurgitation jet velocity >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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of intrinsic biventricular function in response to pulmonary valve replacement

Secondary Outcome Measures

Name	Time	Method
Quantification of changes in biventricular size and function 6 months post valve implantation using CMR