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临床试验/ISRCTN23538073
ISRCTN23538073已完成未知

The effectiveness on post-­operative recovery of using ‘off pump’ self­-expanding tissue valves versus ‘on pump’ conventional tissue valves for pulmonary valve replacement: An early phase randomised controlled trial

niversity of Bristol0 个研究点目标入组 19 人开始时间: 2016年1月20日最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
19
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30944136 protocol (added 10/05/2019) 2023 Results article in https://doi.org/10.1136/bmjopen-2022-065192 (added 02/06/2023)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •1. Patients undergoing either:
  • •1.1. Pulmonary valve replacement (PVR) or
  • •1.2. Pulmonary valve replacement (PVR) with PFO closure that would not require CPB if using an injectable valve or
  • •1.3. Pulmonary valve replacement (PVR) with RVOT reconstruction that does not require CPB if using an injectable valve
  • •2. Patients aged 12-­80 years old inclusive, with an adult valve size (25­31mm)

排除标准

  • •1. Prisoners and adults lacking capacity to consent
  • •2. Patients aged 12 to 15 years old under the care of social services
  • •3. Patients with pulmonary valve or artery stenosis requiring patch reconstruction of the pulmonary arteries using CPB
  • •4. Patients having an intra-­cardiac shunt that would require CPB despite using an injectable valve
  • •5. Patients having a RVOT reconstruction that would require CPB despite using an injectable valve
  • •6. Patients requiring other anatomical heart corrections that would require CPB despite using an injectable valve
  • •7. Patients who are unwilling to undergo surgery involving a porcine product
  • •8. Patients unable to provide assent/consent

研究者

发起方
niversity of Bristol

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