跳至主要内容
临床试验/DRKS00020854
DRKS00020854招募中不适用

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 个研究点目标入组 20 人开始时间: 2020年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
one 至 one(—)
性别
All

入选标准

  • 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

排除标准

  • - 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

研究者

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

相似试验