NL-OMON46072
Completed
Not Applicable
Clinical evaluation of the Transcatheter Renal Venous Decongestion (TRVD) System for renal venous decongestion in patients with Acute Decompensated Heart Failure (ADHF) - TRVD II
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Decompensated Heart Failure
- Sponsor
- Magenta Medical Ltd.
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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