Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- All-cause mortality
研究概览
简要总结
This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •clinically significant primary mitral regurgitation
- •patient underwent M-TEER
- •echocardiography data at baseline, procedure and follow-up
- •follow-up of at least 12 months
- •Exclusion Criteria
- •age under 18 years
排除标准
- 未提供
结局指标
主要结局
All-cause mortality
时间窗: 12 months
Incidence of death from any cause.
Cardiovascular mortality
时间窗: 12 months
Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.
Rehospitalization for congestive heart failure
时间窗: 12 months
Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews or medical records.
Re-do mitral valve procedure
时间窗: 12 months
Incidence of unplanned surgical (mitral valve repair or replacement) or transcatheter re-intervention (re-do transcatheter edge-to-edge repair), e.g. as assessed by patient interviews or medical records.
次要结局
- Residual mitral regurgitation(12 months)
- MVARC (Mitral Valve Academic Research Consortium) Technical success(1 day (at exit from the catheterization laboratory))
- Functional success(1 day (at exit from the catheterization laboratory))