Clinical Evaluation of the Transcatheter Renal Venous Decongestion (TRVD™) System for Renal Venous Decongestion in Patients With Acute Decompensated Heart Failure (ADHF)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Feasibility (procedural success)
研究概览
简要总结
A prospective, multi-national, open-label clinical study which is conducted to asses the safety, feasibility and performance of the TRVD™ System in hospital-admitted patients with Acute Decompensated Heart Failure (ADHF) and evidence of reduced left ventricular ejection fraction.
The study will include patients who present with significant venous congestion, as evidenced by clinical, laboratory and imaging signs of fluid retention.
Study participation, for each enrolled subject, will last approximately 3 months post index procedure.
Patients will be evaluated from enrollment until hospital discharge, then at 30, 60, and 90 days post procedure.
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
- •Patient is 18 years of age or older
- •Patient admitted to the hospital with a primary diagnosis of ADHF who is chronically treated with at least one oral loop diuretic.
- •Patient presents at least two of the following clinical signs of manifest volume overload: 3.1 Jugular venous distension 3.2 Dyspnea, rales, or evidence of pulmonary congestion or oedema on admission chest radiography 3.3 Abdominal discomfort compatible with internal organ congestion and/or hepatomegaly 3.4 Peripheral oedema
- •Ultrasonic evidence of IVC plethora, defined as IVC diameter >2.0 cm.
- •BNP levels >300 pg/dL or NT-proBNP >1500 pg/dL .
- •Evidence of cardiac etiology as per cardiac ultrasonography.
- •LVEF =/<40%.
- •CVP (Invasively measured) >/=14 mmHg
- •Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test).
- •Patient understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
排除标准
- •INR >3, use of a NOAC in the past 48 hours or contraindication to systemic anticoagulation with Heparin.
- •Evidence of hemodynamic instability, evidence of shock with organ hypoperfusion, or need for inotropic support.
- •Overt pulmonary oedema, or Respiratory insufficiency/hypoxia (peripheral haemoglobin saturation <90% with supplemental oxygen), need for non-invasive positive pressure ventilation or intubation.
- •Severe renal dysfunction (eGFR before decompensation <45 ml/min/1.73 m2 BSA or <25 on admission).
- •Known renal artery stenosis.
- •Known intrinsic kidney disease (e.g., established diagnosis of diabetic nephropathy with macroproteinuria, chronic glomerulonephritis).
- •Severe anaemia (haemoglobin <9 mg/dL).
- •Thrombocytopenia with a platelets count <100,
- •Acute coronary syndrome within 4 weeks prior to admission.
- •Active myocarditis or hypertrophic obstructive cardiomyopathy.
- •Complex congenital heart disease.
- •Severe valvular stenosis.
- •Severe morbid obesity (BMI >35).
- •Fluid retention that is not primarily of cardiac origin (e.g., advanced liver disease, severe hypo-albuminaemia, etc.)
- •Temperature > 38°C (oral or equivalent), or sepsis, or active systemic infection requiring IV anti-microbial treatment.
- •Large ascites per ultrasound/CT.
- •Cognitive impairment.
- •Planned PCI, or more than minor surgery in the next 3 months.
- •Moribund patient, or patient with malignancy or other comorbidities limiting life expectancy to less than one year.
- •Patient has a known allergy to Nickel.
- •Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication.
- •Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.
研究组 & 干预措施
TRVD Therapy
干预措施: TRVD Therapy (Device)
结局指标
主要结局
Feasibility (procedural success)
时间窗: Hospital discharge (at least 96 hours following index procedure)
Rate of procedural success (defined as absence of device-related SAEs) at hospital discharge.
Feasibility (technical success)
时间窗: Hospital discharge (at least 96 hours following index procedure)
Rate of technical success (defined as successful delivery and deployment, adequate function during device operation and successful retrieval) at hospital discharge.
Preliminary Safety (device- and procedure-related SAEs)
时间窗: 30 days post index procedure
Incidence of device- and procedure-related SAEs
次要结局
- Initial performance (effectiveness of renal venous pressure reduction)(Up to 24 hours)