NCT02444286撤回不适用
Observational Study of Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation - Follow Up of the Former Participants in the RESHAPE-HF Trial (Abbott Vascular).
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH2 个研究点 分布在 1 个国家开始时间: 2017年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- cardiovascular (CV) death
研究概览
简要总结
To evaluate the safety and efficiency of the MitraClip system in the treatment of patients with clinically significant mitral regurgitation with New York Heart Association (NYHA) Functional Class II to IV chronic heart failure.
详细描述
The purpose of the RESHAPE-HF1-FU Study is to follow up the safety and effectiveness of the MitraClip System in the treatment of clinically significant Functional Mitral Regurgitation (FMR) in patients with New York Heart Association (NYHA) Functional Class III or IV chronic heart failure, former participants in the RESHAPE-HF Trial (Abbott Vascular).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Former participant in the RESHAPE-HF Trial (Abbott Vascular)
- •Subject agrees to return for all required follow-up visits
- •The subject has been informed of the nature of the study and agrees to the study's provisions and has provided written informed consent as approved by the respective clinical site's Ethics Committee
排除标准
- •Withdrawal of Informed Consent
- •Subject belongs to a vulnerable population
结局指标
主要结局
cardiovascular (CV) death
时间窗: 24 months
Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death
次要结局
- 6 Minute Walk Test (6MWT)(at 6, 12 and 24 months)
- CV hospitalizations and CV death(24 months)
- Patient-reported Global Assessment (PGA)(6, 12 and 24 months.)
- Mitral Regurgitation (MR) severity reduction(at 12 and 24 months)
- Quality of Life (QoL)(12 months)
- New York Heart Association (NYHA) Functional Class(6, 12 and 24 months)
研究者
研究点 (2)
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