NCT04029363招募中不适用
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
HighLife SAS90 个研究点 分布在 7 个国家目标入组 120 人开始时间: 2019年5月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 90
- 主要终点
- Device Safety
研究概览
简要总结
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
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
- •1. Age ≥ 18 years
- •Moderate-severe or severe mitral regurgitation (≥ 3+)
- •Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
- •Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month
- •Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability
- •Patient meets the anatomical criteria for HighLife valve
- •Patient is willing to participate in the study and provides signed informed consent
排除标准
- •Any stroke/TIA within 30 days
- •Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
- •Active infections requiring antibiotic therapy
- •Active ulcer or gastro-intestinal bleeding in the past 3 months
- •History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
- •Patients in whom TEE is not feasible
- •Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
- •Patient is unable to comply with the follow-up schedule and assessments
- •Participation in another clinical investigation at the time of inclusion
- •Patient has known allergies to the device components or contrast medium
- •Patient cannot tolerate anticoagulation or antiplatelet therapy
- •Patients with a life expectancy of less than 12 months due to non-cardiac conditions
- •Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months
结局指标
主要结局
Device Safety
时间窗: 30 days
Freedom from major adverse events
次要结局
未报告次要终点
研究者
研究点 (90)
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