NCT03523416进行中（未招募）不适用
Early Feasibility Study Of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW US)
Edwards Lifesciences30 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2018年7月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
- 试验地点
- 30
- 主要终点
- Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)
研究概览
简要总结
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
详细描述
The early feasibility study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt 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
- •Symptomatic Heart Failure (HF):
- •NYHA class II with a history of > II; III; or ambulatory IV AND
- •≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12 months; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months prior to study entry.
- •On stable Guideline Directed Medical Therapy (GDMT) for heart failure
- •At rest: elevated LAP (or PCWP) of > 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by > 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP) pressure of > 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by > 10 mmHg
- •Left Ventricular Ejection Fraction (LVEF) ≤ 40%
- •Pulmonary Vascular Resistance (PVR) < 4.0 WU
排除标准
- •Severe HF:
- •Stage D, non-ambulatory NYHA Class IV, transplant list
- •If BMI < 30, Cardiac index < 2.0 L/min/m2
- •If BMI ≥ 30, cardiac index < 1.8 L/min/m2
- •Left Ventricular End-Diastolic Diameter (LVEDD) > 8 cm
- •LVEF < 20%
- •Valve disease: MR > 3+ or > moderate MS, TR > 2+, AR > 2+ or > moderate AS
- •MI or therapeutic invasive cardiac procedure < 3 months
- •TIA, stroke, CRT implanted < 6 months
- •RV dysfunction > mild by TTE OR TAPSE < 1.2 OR RV size ≥ LV size by TTE, OR right ventricular fractional area change (RVFAC) ≤ 25%
- •Dialysis OR renal dysfunction (S-CR > 2.5 mg/dl OR eGFR < 25 ml/min/1.73m2)
- •6MWT < 50m OR > 600m
- •Active endocarditis or infection < 3 months
- •Mean Right Atrial Pressure (mRAP) > 15 mmHg at rest
- •Body Mass Index (BMI) ≥ 45 kg/m2
结局指标
主要结局
Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)
时间窗: 30 days
Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.
次要结局
- Rate at which device is successfully implanted (Device Success)(Day 0)
- Rate at which device is patent and subject is discharged from hospital without the need for additional intervention for the device (Procedural Success)(10 days post-op)
- Rate at which the procedure is successful without major cardiac/cerebrovascular/renal events and re-intervention (Clinical Success)(30 days)
- Change in the ratio of systemic blood flow (Qs) to the pulmonary blood flow (Qp), called "Qp/Qs", from Baseline to Follow Up(3 months, 6 months)
- Change in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up(3 months, 6 months)
- Change in mean systolic & diastolic pulmonary artery pressure (PAP) and change in mean right atrial pressure (RAP) from Baseline to Follow Up(3 months, 6 months)
- Change in Pulmonary Vascular Resistance (PVR) from Baseline to Follow Up(3 months, 6 months)
- Change in two parameters related to Tricuspid Annular Plane Excursion (TAPSE) from Baseline to Follow Up(3 months, 6 months)
研究者
研究点 (30)
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