HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients With Moderate-severe or Severe MR, High Surgical Risk and With a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 18
- 主要终点
- Rate of subjects meeting Technical Success
研究概览
简要总结
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
详细描述
Study to assess the feasibility, safety, and performance of the HighLife CLARITY TSMV, and its deliver systems, in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment according to the local multidisciplinary Heart Team decision, and who are at high risk for potential LVOT obstruction(LVOTO).
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
- •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 for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
- •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
- •Patients with a high risk for LVOTO
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
Rate of subjects meeting Technical Success
时间窗: 24 hours
* Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm CLARITY TSMV * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE * Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm CLARITY TSMV * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE
次要结局
未报告次要终点