NL-OMON46587撤回不适用
The safety and feasibility evaluation of the Doraya catheter in subjects with Acute Heart Failure - Doraya FIH Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 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) Subject is >18 and <85 years of age.
- •2) Subject is hospitalized with primary diagnosis of congestive AHF.
- •3) Evidence of fluid overload as indicated by 2 or more of the following criteria:
- •a) peripheral edema *2+
- •b) jugular venous distension *7 cm H2O
- •c) radiographic pulmonary edema or pleural effusion
- •d) enlarged liver or ascites
- •e) pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea.
- •4) Subject insufficiently responds to standard diuretic therapy, meeting the following criteria:
- •Sufficient diuretic treatment:
- •a) >80 mg furosemide per day or an equivalent, or;
- •b) >1.5X of the subject chronic baseline diuretic level
- •With at least of one of the following:
- •a) reduction of <1 Kg/day in subject weight, or;
- •b) <1ml/kg/hour Urine output (for a duration of at least 4 hours), or;
- •c) IVC with no inspiratory collapse by cardiac ultrasonography
- •5) Brain natriuretic peptide (BNP) *400 pg/mL or N-terminal-pro-brain natriuretic peptide (NT-proBNP) *1,600 pg/ mL.
- •6) Subject understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
- •7) Subject is willing and able to comply with the specified study requirements and follow-up assessments, and can be contacted by telephone.
- •8) Evidence of cardiac etiology as per cardiac ultrasonography.
- •9) IVC with no inspiratory collapse by cardiac ultrasonography.
- •10) Urine output <1ml/kg/hour, for minimum duration of 4 hours, preferably measured through a urinary catheter.
- •11) CVP>12 mmHg confirmed at the beginning or prior to the catheterization procedure.
排除标准
- •1) Systolic blood pressure <90 mmHg at the time of screening.
- •2) Acute myocardial infarction or acute coronary syndrome within past 7 days.
- •3) Known LVEF < 10% by echocardiography within 1 year prior to enrolment.
- •4) Complex congenital heart disease (e.g. Tetralogy of Fallot subjects, single ventricle physiology).
- •5) Known active myocarditis, hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade.
- •6) Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis\severe regurgitation) or Severe mitral disease with planned intervention.
- •7) Severe renal dysfunction (eGFR <18 ml/min/1.73 m2 BSA) or subject is on chronic dialysis.
- •8) Subject has history of deep vein thrombosis and/or pulmonary embolism
- •9) Evidence of cardiogenic shock with organ hypo-perfusion.
- •Current or need of mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device),
- •10) Subject with bleeding disorder which limit the use of antiplatelet and/or anticoagulant therapy (e.g. Thrombocytopenia with platelets count <100,000, anemia with hemoglobin <9 mg/dL)
- •11) Subjects with a known infra-renal IVC diameter of <14mm
- •12) Open or infected wounds in the legs.
- •13) Subject is pregnant or lactating. Pregnancy confirmed by positive urine or serum test.
- •14) Subject with advanced liver disease or serum Albumin<2.5 g/dL
- •15) Evidence of active systemic infection (documented by either one of the following: fever >38°C, ongoing uncontrolled known infection (i.e. inflammatory parameters not decreasing despite * 48 hrs of antibiotic treatment)
- •16) Severe obesity (BMI >35).
- •17) Subject with known hypersensitivity to Nickel.
- •18) Subject with history of radiation therapy to lower abdomen.
- •19) Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication.
- •20) Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems or requiring inotropic therapy for survival.
- •21) Concomitant disease expected to cause death in * 90 days
- •22) Any other medical, social, or psychological issues that in the opinion of the investigator preclude the subject from receiving this treatment, or the procedures and evaluations pre- and post-.
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