Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 6
- 主要终点
- recurrent mitral valve insufficiency > grade 2
研究概览
简要总结
Functional mitral insufficiency poses a challenge with regard to the optimal time of intervention, particularly because they are frequently associated with left ventricular (LV) dilation and reduced LV ejection fraction (EF). The registry will document the underlying pathology by using transthoracal echo cardiography (TTE) with analysis of common tenting parameters. OP strategies, data and outcomes will be documented, as well as follow-up data for echocardiography, quality of life and MACCE outcomes after 6 months, 1 and 2 years.
详细描述
Prospective enrolment of all patients with mitral valve insufficiency and restricted movement of leaflets during systole into a multicentric registry. Exact analysis of the underlying pathology using TTE with analysis of tenting parameters. In patients without contraindications, functional preoperative MRT to determine the functional reserve of ventricular function. Documentation of the quality of life of the patients using the SF12 questionnaire before and after intervention. Documentation of follow-up data (SF12, TTE, NT-pro BNP) at 6 months, 1 and 2 years. Development of operative strategies to improve long-term outcomes in patients with severe LV dilation (typically accompanied by function mitral insufficiency type IIIb).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •functional mitral valve insufficiency with reduced mobility of leaflets during systole (type IIIb) - effective regurgitation orifice area > 20 mm2 / regurgitant volume > 30 ml/beat
- •left ventricular ejection fraction <= 50% and /or left ventricular end-diastolic diameter >= 60 mm
- •tenting of the proximal and / or anterior mitral leaflets
排除标准
- •prolaps of leaflets (type II mitral regurgitation)
- •combination intervention with aortic valve repair or replacement
- •re-operation at mitral valve
结局指标
主要结局
recurrent mitral valve insufficiency > grade 2
时间窗: 2 years
see above
次要结局
- MACCE(1 year)
- re-intervention at mitral valve(2 years)
- cardiovascular mortality(2 years)
- device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure(2 years)
- re-hospitalisation due to heart failure(2 years)