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Clinical Trials/DRKS00020854
DRKS00020854
Recruiting
N/A

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

Klinik für Kinderkardiologie und angeborene Herzfehler Deutsches Herzzentrum München Klinik an der Technischen Universität München0 sites20 target enrollmentFebruary 25, 2020
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ConditionsQ20.8Other congenital malformations of cardiac chambers and connections

Overview

Phase
N/A
Intervention
Not specified
Conditions
Q20.8
Sponsor
Klinik für Kinderkardiologie und angeborene Herzfehler Deutsches Herzzentrum München Klinik an der Technischen Universität München
Enrollment
20
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 25, 2020
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

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

Eligibility 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 (\<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

Outcomes

Primary Outcomes

Not specified

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