NCT00348829终止2 期
Mitral Valve Reconstruction in Patients With Chronic Heart Failure and Secondary Mitral Insufficiency: Identification of Predictors for a Successful Therapy
University of Leipzig2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2006年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure
研究概览
简要总结
The aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients with secondary mitral insufficiency and CHF.
- Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in CHF patients.
- Collection of clinical factors for the assessment of the postoperative course after mitral valve reconstruction in CHF patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Dilatative Cardiomyopathy with LVEF < 35%
- •NYHA III oder IV under maximal medical treatment
- •Angiographic and hemodynamic MI > II° (LAP- mean pressure > 15-20 mmHg; LA v-wave-oder PCWP v-wave > 35 mmHg under exercise)
- •Echocardiographic MI > II°
- •At least 1 hospitalization for heart failure before OP
排除标准
- •Secondary Cardiomyopathy by vitium cordis
- •Planned secondary procedure like CABG, aortic valve surgery, surgery of the tricuspid valve etc
- •Inclusion in another trial
- •Euro-Score > 30%
- •Former valve operation or CABG
结局指标
主要结局
Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure
时间窗: 3 months
次要结局
- Identification of clinical factors for the postoperative outcome(3 months)
研究者
Sven Möbius-Winkler
PD Dr. med.
University of Leipzig
研究点 (2)
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