ACTRN12620000564954招募中未知
Evaluation of Outcomes Following Tricuspid Valve Cylinder Reconstruction with CardioCel® in Isolated Severe Tricuspid Regurgitation
The Alfred0 个研究点目标入组 10 人开始时间: 2020年5月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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 85 Years（—）
- 性别
- All
入选标准
- •Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
- •Aged 18-85 years, inclusive
- •Symptomatic with TR grade greater than or equal to 3+
- •Preserved right ventricular function
- •In the opinion of the investigator and heart surgery team, the patient is not an appropriate candidate for tricuspid annuloplasty
排除标准
- •In the opinion of the investigator and heart surgery team, the patient is an appropriate candidate for tricuspid annuloplasty
- •Haemodynamic instability (systolic pressure < 90mmHg without after load reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
- •Model for End-stage Liver Disease (MELD score) > 15
- •Suspected inability to adhere to adhere to follow-up
- •Patients in whom TTE, TOE, (or MRI) is contraindicated
- •A known need for any other cardiac surgery
- •Inability to give informed consent
研究者
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