NL-OMON33336撤回不适用
Cardioblate Closure Device Closed Thorax Trial:An Evaluation of the Cardioblate® Closure* Device in Facilitating Occlusion of the Left Atrial Appendage in Closed Thorax Surgeries - Cardioblate Closure Device Closed Thorax Trial
Cardiovascular Department SHD/RST0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 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
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects who meet the following criteria should be considered for the study:
- •1) >18 and < 80 years of age
- •2) Concomitant indication for closed thorax cardiac surgery for one or more of the following:
- •a. Mitral valve repair or replacement
- •b. Aortic valve repair or replacement
- •c. Tricuspid valve repair or replacement
- •d. CABG for subjects >60 years of age
- •e. CABG for subjects <60 years of age with a history of AF
- •f. Surgical ablation or Maze procedure
- •3) The subject is willing and able to provide written informed consent and comply with study requirements
排除标准
- •Subjects who meet any of the following criteria should not be considered for the study:
- •1) Thrombus in LAA and/or LA
- •2) Prior LAA isolation attempt(s)
- •3) Patient is contraindicated for an intra-operative transesophageal echocardiogram (TEE)
- •4) Unable to take an anticoagulant during the study follow-up period
- •5) Subject is undergoing an emergency cardiac procedure
- •6) Life expectancy of less than 12 months
- •7) Pregnancy or desire to be pregnant within 12 months of the study procedure
研究者
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