NCT04000607进行中（未招募）不适用
Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)
Edwards Lifesciences2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年7月10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
- 45
- 试验地点
- 2
- 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 Exploratory study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE 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 HF:
- •NYHA II w/ history of > II; III; or ambulatory IV AND
- •≥1 HF hospitalization OR treatment with IV or oral diuresis within 12 months OR Elevated NT-proBNP 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 GDMT for HF
- •Left Ventricular Ejection Fraction (LVEF) ≤ 40% as determined by site cardiologist
- •Hemodynamic criteria
- •o At rest: Elevated LAP (or PCWP) > 15 mmHg AND LAP > RAP + 5 mmHg AND/OR supine ergometer exercise: elevated LAP (or PCWP) > 25 mmHg AND LAP > RAP + 10 mmHg
- •Pulmonary Vascular Resistance (PVR) < 5.0 WU as determined by site cardiologist
排除标准
- •Severe HF:
- •NYHA IV, stage D, non-ambulatory, transplant list
- •Cardiac index ≤ 1.5 L/min/m2
- •Left Ventricular End-Diastolic Diameter (LVEDD) > 8 cm
- •LVEF <20%
- •Valve disease
- •MR >3+ or > moderate MS, TR >3+ (severe on 5-point scale), 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 > 220 micromol/L OR e-GFR < 25ml/min/1.73 m2)
- •6MWT <50m OR >400m
- •Active endocarditis or infection < 3 months
- •Mean Right Atrial Pressure (mRAP) > 15 mmHg as determined by site cardiologist
- •Body Mass Index (BMI) ≥ 45 kg/m2
研究组 & 干预措施
Edwards APTURE transcatheter shunt system
Experimental
干预措施: APTURE transcatheter shunt (Device)
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 (2)
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