NCT04334694Unknown不适用
Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER) Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical improvement
研究概览
简要总结
The aim of the study is to assess invasive and non-invasive parameters that may predict clinical improvement in patients with congestive heart failure after implantation of Occlutech® Atrial flow regulator (AFR) device.
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
- •Symptomatic heart failure (HF) in NYHA class III or IV ambulatory
- •Optimal medical therapy of HF according to European Society of Cardiology (ESC) guidelines for last 6 months
- •Hospitalization because of HF decompensation in last 12 months
- •Absence of significant valvular disease requiring cardiac surgery
- •Life expectancy ≥ 1 year
- •Written informed consent obtained from the patient
- •Left ventricle ejection fraction (LVEF) ≥ 15%
- •Elevated left heart filling pressures:
- •Pulmonary artery wedge pressure (PAWP) at rest > 15 mmHg or
- •PAWP > 25 mmHg during hand grip test
排除标准
- •Participation in another clinical trial in last 30 days
- •Acute infection or sepsis
- •Severe coagulation disorder
- •Allergy to nickel or titanium
- •Severe peripheral artery disease disabling 6 minutes walk test
- •Allergy to antiplatelet drugs, oral anticoagulants or heparin
- •Contraindication to trans-oesophageal echocardiography (TEE)
- •Pregnancy
- •Atrial septal defect (ASD) or presence of atrial septal occluder
- •Severe patent foramen ovale (PFO) with significant left to right shunt in rest
- •Intracardiac thrombus
- •Acute coronary syndrome or Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) in last 6 months
- •Severe pulmonary hypertension:
- •Right atrial pressure ≥ PAWP (measured in right heart catheterization)
- •Right atrial pressure > 20 mmHg (measured in right heart catheterization)
- •Planned heart transplantation
- •Transient ischemic attack or stroke within last 6 months
- •Cardiac resynchronisation therapy (CRT) within last 6 months
结局指标
主要结局
Clinical improvement
时间窗: 12 months
Increase in 6 minutes walk test distance
次要结局
- Clinical improvement II(12 months)
- Device related adverse event(12 months)
研究者
研究点 (2)
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