NL-OMON46072已完成不适用
Clinical evaluation of the Transcatheter Renal Venous Decongestion (TRVD) System for renal venous decongestion in patients with Acute Decompensated Heart Failure (ADHF) - TRVD II
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient is 18 years of age or older
- •2. Patient admitted to the hospital with a primary diagnosis of ADHF who is chronically treated with at least one oral loop diuretic.
- •3. 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
- •4. Ultrasonic evidence of IVC plethora, defined as IVC diameter >2.0 cm.
- •5. BNP levels >300 pg/dL or NT-proBNP >1500 pg/dL .
- •6. Evidence of cardiac etiology as per cardiac ultrasonography.
- •7. LVEF 8. CVP (Invasively measured) >/<= 14 mmHg
- •9. Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test).
- •10. Patient understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
- •11. Patient is willing and able to comply with the specified study requirements and follow-up evaluations, and can be contacted by telephone.
排除标准
- •Clinical and general criteria: ;1. INR >3, use of a NOAC in the past 48 hours or contraindication to systemic anticoagulation with Heparin.
- •2. Evidence of hemodynamic instability, evidence of shock with organ hypoperfusion, or need for inotropic support.
- •3. Overt pulmonary oedema, or Respiratory insufficiency/hypoxia (peripheral haemoglobin saturation <90% with supplemental oxygen), need for non-invasive positive pressure ventilation or intubation.
- •4. Severe renal dysfunction (eGFR before decompensation <45 ml/min/1.73 m2 BSA or <25 on admission).
- •5. Known renal artery stenosis.
- •6. Known intrinsic kidney disease (e.g., established diagnosis of diabetic nephropathy with macroproteinuria, chronic glomerulonephritis).
- •7. Severe anaemia (haemoglobin 8. Thrombocytopenia with a platelets count <100,000.
- •9. Acute coronary syndrome within 4 weeks prior to admission.
- •10. Active myocarditis or hypertrophic obstructive cardiomyopathy.
- •11. Complex congenital heart disease.
- •12. Severe valvular stenosis.
- •13. Severe morbid obesity (BMI >35).
- •14. Fluid retention that is not primarily of cardiac origin (e.g., advanced liver disease, severe hypo-albuminaemia, etc.)
- •15. Temperature > 38°C (oral or equivalent), or sepsis, or active systemic infection requiring IV anti-microbial treatment.
- •16. Large ascites per ultrasound/CT.
- •17. Cognitive impairment.
- •18. Planned PCI, or more than minor surgery in the next 3 months.
- •19. Moribund patient, or patient with malignancy or other comorbidities limiting life expectancy to less than one year.
- •20. Patient has a known allergy to Nickel.
- •21. Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication.
- •22. Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints. ;CT Imaging: ;Patient has renal venous anatomy that is unsuitable for device placement for treatment,
- •23. Renal vein length 24. Renal vein diameter /= 16 mm.
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