NCT04343313招募中不适用
Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients With Severe, Symptomatic Mitral Regurgitation
Half Moon Medical9 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月8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
- 30
- 试验地点
- 9
- 主要终点
- Adverse Events
研究概览
简要总结
The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+)
- •Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy (GDMT) determined by the local multidisciplinary heart team
- •Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not appropriate for commercially approved transcatheter mitral valve therapies
- •Native mitral valve geometry and size compatible with the Half Moon TMVr implant
- •Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System
- •Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits
排除标准
- •Prior transseptal intervention with occlusion device currently implanted
- •Implanted with venous stents (iliac and femoral) including inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access with the delivery system
- •Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation
- •Prohibitive mitral annular or leaflet calcification
- •Diseased mitral anterior leaflet such as flail or prolapse
- •Left ventricular ejection fraction (LVEF) < 25%, or LVEF 25-30% in the presence of left ventricular end diastolic volume index (LVEDVi) >120mL/m2 as measured by resting echocardiogram within 30 days of the Index Procedure
- •Left ventricular end diastolic diameter (LVEDD) > 75mm
- •Pulmonary hypertension with resting pulmonary artery systolic pressures ≥ 2/3 systemic systolic pressure
- •Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction
- •Severe tricuspid regurgitation
- •Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure
- •Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment
- •Prior stroke, TIA, or myocardial infarction within 90 days
- •Need for coronary revascularization
- •Severe symptomatic carotid artery stenosis
- •Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc
- •Need for emergent surgery
- •Endocarditis within 6 months
- •Subject is unwilling or unable to adhere to the protocol recommended anticoagulation treatment
- •GI bleeding within 6 months
- •History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion
- •Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support
- •Platelet count of <75,000 cells/mm3
- •Renal insufficiency (Creatinine > 2.5 mg/dL)
- •Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics)
- •Contraindication to transesophageal echocardiography (TEE)
- •Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically
- •Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment)
- •Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint
结局指标
主要结局
Adverse Events
时间窗: 30 Days
Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device
次要结局
- Device Durability(30 Days (+ annually through 5 years))
- Device Placement(30 Days (+ annually through 5 years))
- Device Performance(30 Days (+ annually through 5 years))
- Symptom Improvement(30 Days (+ annually through 5 years))
研究者
研究点 (9)
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