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临床试验/ACTRN12620001070921
ACTRN12620001070921尚未招募未知

Evaluating the Effect of Transesophageal Echocardiography (TOE)- Guided Device Lead Positioning on the development of new or worsening tricuspid regurgitation – the REDUCE-TR Study.

Royal Prince Alfred Hospital0 个研究点目标入组 125 人开始时间: 2020年10月19日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
入组人数
125

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1.Clinical indication for device implantation (permanent pacemaker or debfibrillator)
  • 2.Greater than or equal to 18 years of age
  • 3.Able to provide informed consent

排除标准

  • 1.Previous endocardial lead
  • 2.Moderate or greater tricuspid regurgitation on baseline transthoracic echocardiography
  • 3.Moderate or severe right ventricular dilatation or systolic dysfunction
  • 4.Estimated right ventricular systolic pressure >70mmHg
  • 5.Suboptimal 3D-TOE images at time of device-implantation
  • 6.Unable to attend 6-month follow up at a designated echo centre.
  • 7. Complete heart block
  • 8. Rapid atrial fibrillation
  • 9. More than one lead across tricuspid valve planned (E.g. His bundle backup lead)

研究者

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