Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 47
- 主要终点
- Mitral insufficiency grade 2+ or more
研究概览
简要总结
This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR). The registry primarily focuses on patients treated with TMVR in real-world clinical practice.
Patients evaluated for TMVR but not undergoing the procedure are no longer systematically included. Historical data may include such patients who subsequently underwent alternative treatments, including transcatheter edge-to-edge repair, mitral valve surgery, or medical/conservative therapy.
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 mitral insufficiency
- •patient underwent screening for TMVI
- •echocardiography data at baseline (and after TMVI, E2E and surgery)
- •follow-up of at least 30 days
排除标准
- •- age under 18 years
结局指标
主要结局
Mitral insufficiency grade 2+ or more
时间窗: 12 months
Mitral insufficiency measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.
Freedom from device-related complications
时间窗: 30 days
次要结局
- Combined all-cause mortality or rehospitalization for congestive heart failure(12 months)
- Rehospitalization for congestive heart failure(12 months)
- Unplanned mitral valve intervention(12 months)
- All-cause mortality(12 months)
- Cardiovascular mortality(12 months)
- Combined cardiovascular mortality or rehospitalization for congestive heart failure(12 months)
- Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention(12 months)
- Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention(12 months)
- New York Heart Association (NYHA) stage III or IV(12 months)
研究者
Sebastian Ludwig
Sebastian Ludwig, M.D., Principal Investigator
Universitätsklinikum Hamburg-Eppendorf