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:
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
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
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