First in Human Safety Study of the Synecor Conveyor System Used for Delivery of a Minimally Invasive Mitral Valve
试验速览
- 阶段
- 不适用
- 发起方
- Synecor, LLC
- 入组人数
- 10
- 主要终点
- Correct Positioning of Implant
研究概览
简要总结
To demonstrate that the Conveyor System can safely provide left ventricular access to deliver the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients who have been diagnosed with prior mitral valve replacement or repair (failing bioprosthetic mitral valve) who are candidates for mitral valve-in-valve procedure.
详细描述
This is a prospective, non-randomized, multi-center early feasibility study designed to demonstrate that the Conveyor System can safely provide left ventricular access to deliver an Edwards SAPIEN 3 TAVR valve into the mitral valve position in a valve-in-valve procedure. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed insufficient, or combined).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject is able and willing to comply with all assessments in the study.
- •Subject or subjects' legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
- •Age of Subject is ≥
- •Estimated life expectancy >6 months.
- •Patients demonstrated to have symptomatic post-therapeutic mitral valve dysfunction as determined at diagnostic cardiac catheterization, echocardiography, and/or MR and a mitral valve annulus suitable for a "valve in valve" transcatheter valve replacement procedure using the Edwards SAPIEN 3™ TAVR device based on diagnostic cardiac catheterization, echocardiography and/or MR imaging.
- •Patient has been evaluated by a Heart Team and judged to be a candidate for mitral valve in valve procedure.
- •Patient has femoral and iliac artery dimensions sufficient to accept the study device (>6 mm).
- •Patient is potential surgical candidate.
排除标准
- •Patients with any clinical presentation that will exclude them from receiving a Edwards SAPIEN 3™ percutaneous valve.
- •Patients with vascular disease that would preclude navigation of the Conveyor System.
- •Patients who do not desire to participate in the study.
- •Patients who are judged to be mentally incapable of fully understanding the risks or potential benefits of participation in the study.
- •Patients with visible thrombus in the left atrium or on the mitral valve apparatus/replacement.
- •Patient requires urgent or emergent treatment.
- •Patient has significant aortic valve disease or previous aortic valve replacement.
- •Pregnant patients (must have negative pregnancy test).
结局指标
主要结局
Correct Positioning of Implant
时间窗: 30 Days
The ability of the Conveyor System to safely position the valve delivery system to facilitate correct positioning of the implant without causing any serious adverse events through 30-day follow up. Cineangiography will be used in delivery to ensure that the implant is orthogonal to the mitral valve annulus and centered within it from multiple views. The patient will be seen in the clinic in a routine follow-up to ascertain any untoward clinical signs or symptoms.
次要结局
未报告次要终点