Abbott Cephea Mitral Valve Disease 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
- 32
- 主要终点
- Primary Objective
研究概览
简要总结
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.
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
- •Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis.
- •New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.
- •In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.
- •Age 18 years or older at time of consent.
- •The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.
排除标准
- •Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
- •Subject is undergoing dialysis or experiencing chronic renal failure
- •Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use
- •Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.
- •Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.
研究组 & 干预措施
Potential transcatheter mitral valve replacement (TMVR) candidates
Patients with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement.
结局指标
主要结局
Primary Objective
时间窗: From enrollment to 2 years of follow-up
The objective of the MVD Registry is to collect data on the progression of MVD patients considered for TMVR therapy to guide product development, regulatory submissions, and reimbursement planning
次要结局
未报告次要终点