ACTRN12616000306415已完成未知
Safety and Feasibility Study of the Tempo (Trademark) Temporary Pacing Lead in patients undergoing a transcatheter cardiac procedure requiring temporary intracardiac pacing in New Zealand
BioTrace Medical Inc.0 个研究点目标入组 25 人开始时间: 2016年3月9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
- 25
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Subject requires temporary intracardiac pacing.
- •Subject is a surgical candidate and able to tolerate general anesthesia.
- •Subject scheduled to undergo TAVR, BAV or an EP procedure.
排除标准
- •Subject has a prosthetic tricuspid valve.
- •Subject has a history of known coagulopathy and/or thrombocytopenia (platelets <100).
- •Immediately prior to the procedure, there is presence of greater than mild pericardial effusion.
- •Subject has a history of major bleeding within previous 6 months of the planned procedure, or an absolute contraindication to anticoagulation therapy.
- •For EP Subjects Only: Subject may not be 75 years of age or older at the time of consent (inclusive).
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