DORAYA-HF Early Feasibility Study

Criteria the registry did not label

• INCLUSION.
• Subject is \>18 years of age.
• Subject is hospitalized with primary diagnosis of ADHF.
• N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL for body-mass index (BMI) ≤25.
• Evidence of fluid overload as indicated by 2 or more of the following criteria:
  • peripheral edema ≥ 2+
  • radiographic pulmonary edema or pleural effusion
  • enlarged liver or ascites
  • pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
  • Jugular venous distention \> 7 cmH2O
• IVCCI \< 50% by cardiac ultrasonography or elevated CVP (or RAP) ≥12 mmHg (Invasively measured).
• Subject insufficiently responds to IV diuretic therapy defined as average hourly urine output \<125ml/hour over 6 hours OR cumulative urine output \< 3L over 24 hours OR a Net Fluid Loss \<375mL in a 12-hour timeframe following ≥2 diuretic challenges with a minimum of:
  • 1st diuretic dose: ≥2X chronic oral daily dose (IV) or 80 mg IV Lasix or equivalent.
  • 2nd diuretic dose: ≥ 80 mg IV Lasix or equivalent.
• Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study. Females of child-bearing potential must have a negative pregnancy test.
  • Procedural Inclusion Criterion
• CVP (or RAP) ≥12 mmHg and PCWP ≥ 18 mmHg confirmed in the Cath Lab, via femoral line, pigtail, Swan Ganz, or other indwelling catheter.
  • EXCLUSION
• Systolic blood pressure \<90 mmHg at the time of screening.
• Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days.
• Known LVEF \< 10% by echocardiography within 1 year prior to enrollment.
• Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
• Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
• Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.
• Subject has severe renal dysfunction, defined as either eGFR \<25 ml/min/1.73 m2 BSA on admission or on renal replacement therapy.
• Subject with advanced liver disease: either Total Bilirubin \> 4 mg/dL or Serum sodium (corrected for glucose) \< 125 mmol/L.
• Treatment with high dose IV inotropes within 2 days prior to enrollment. High dose is defined as \> 1 unit of inotrope (excluding Digoxin) as follows: 5 µg/kg/min dopamine = 1 unit, 5 µg/kg/min dobutamine= 1 unit, 0.375 µg/kg/min milrinone = 1 unit.
• Subject with a history of:
  • Deep vein thrombosis that occurred \< 6 months prior to enrollment, and/or;
  • Pulmonary embolism episode that occurred \< 6 months prior to enrollment.
• Evidence of active systemic infection documented by either one of the following: fever \>38°C/100°F, or ongoing uncontrolled infection (i.e. inflammatory parameters not decreasing despite \> 48 hrs of antibiotic treatment).
• Subjects with a known infra-renal IVC diameter of \<16mm.
• Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.