NCT03382457进行中（未招募）不适用
Clinical Study of Edwards Cardioband FIT Valve Repair System
Edwards Lifesciences18 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 18
- 主要终点
- Primary Performance Endpoint - Intraprocedural Success
研究概览
简要总结
Clinical Study of the Edwards Cardioband FIT Repair System
详细描述
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards Cardioband FIT Repair System
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
- •Tricuspid regurgitation (moderate or greater)
- •Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
- •The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid reconstruction
- •Patient is willing and able to comply with all specified study evaluations and provides written informed consent
排除标准
- •Patients with conditions or anatomical considerations that preclude safe and successful procedure-related or study device access, deployment, or function, including but not limited to:
- •Patients in whom transesophageal echocardiography is contraindicated or cannot be completed.
- •Patients in whom tricuspid valve anatomy is not evaluable by TTE or TEE
- •Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), polyester, or contrast media.
- •Previous tricuspid valve repair or replacement with device in place
- •Presence of trans-tricuspid pacemaker or defibrillator leads where: (a)TR is a result of impingement on the tricuspid valve leaflet as evaluated by echocardiography; or (b) implanted in the RV within the last 90 days
- •Primary tricuspid valve disease
- •Any physical impairment which limits the patient's capacity to complete functional testing due to other medical conditions independent of their TR (e.g., orthopedic condition)
- •Currently participating in another investigational biologic, drug, or device study
- •Any of the following cardiovascular procedures:
- •Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
- •Carotid surgery within the last 30 days
- •Direct current cardioversion within the last 30 days
- •Leadless RV pacemaker implant within the last 30 days
- •Cardiac surgery within the last 90 days
- •Any of the following underlying medical conditions:
- •Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
- •Active endocarditis or infection requiring antibiotic therapy (oral or intravenous)
- •Hemodynamically significant pericardial effusion
- •Significant intra-cardiac mass, thrombus, or vegetation
- •Untreated clinically significant coronary artery disease (CAD) requiring revascularization, evidence of acute coronary syndrome, or recent myocardial infarction (MI)
- •Known history of untreated severe symptomatic carotid stenosis (>50% by ultrasound) or asymptomatic carotid stenosis (>70% by ultrasound)
- •Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or hemodynamic support within the last 30 days
- •Known bleeding or clotting disorders or patient refuses blood transfusion
- •Active GI bleeding
- •Recent stroke
- •Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months or any planned percutaneous cardiac procedure within the next 90 days
- •Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 6 months
- •Pregnant, breastfeeding, or planning pregnancy within the next 12 months
- •Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
研究组 & 干预措施
Treatment
Experimental
Treatment with the Edwards Cardioband FIT Repair System
干预措施: Transcatheter Tricuspid Valve Repair (Device)
结局指标
主要结局
Primary Performance Endpoint - Intraprocedural Success
时间窗: Intraprocedural
Number of patients who had Intraprocedural Success, definition modified from TVARC criteria. Per patient analysis.
Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate
时间窗: 30 days
Number and percentage of patients who experienced at least one major adverse event (MAE).
Primary Performance Endpoint - Clinical Success
时间窗: 30 days and 1 year
Number of patients who had Clinical Success at 30 days and 1 year, definition modified from TVARC criteria. Per patient analysis.
次要结局
未报告次要终点
研究者
研究点 (18)
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