PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair: A Prospective, Single-center, Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Procedural success
研究概览
简要总结
Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team due to a high surgical risk profile.
详细描述
A prospective single-center, open-label study to evaluate the safety and effectiveness of transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System compared to using the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of our mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device. Treating physicians had no influence on scheduling or system selection.
Follow-up examinations will be performed one month and one year after the procedure with assessment of echocardiographic and functional status based on the New York Heart Association (NYHA) grade. Patient characteristics, baseline data, and data related to the procedure were assessed using a registry, medical records and the procedure protocols.
This study is a subproject of the MitraClip® Registry (NCT02033811)
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
- •Age ≥18 years
- •Severe Mitral Regurgitation (3+ to 4+)
- •Symptom status: NYHA functional class ≥ II
- •Patients with FMR or DMR, who were referred for M-TEER by the heart team decision due to a high
排除标准
- •Life expectancy < 1 year
- •Anatomy of the mitral valve that may not be suitable for the MitraClip or PASCAL device
- •Contraindication for transoesophageal echocardiography
- •Active endocarditis
- •Pregnant or planning pregnancy within next 12 months
结局指标
主要结局
Procedural success
时间窗: one month after implantation
as defined by the Mitral Valve Academy Research Consortium (MVARC)
Composite endpoint of all-cause death and heart failure hospitalization
时间窗: one year after implantation
次要结局
- Grade of Mitral Regurgitation(one month and one year after implantation)
- Functional status(one month and one year after implantation)