Evaluation of FlowMod System While Intermittently Partially Occluding Vena Cava Blood Flow in Subjects With ADHF

Prior treatment

• ACS or MI within 30 days prior to enrollment
• Subjects receiving mechanical circulatory support
• Subjects with inadequate jugular vein access due to prior jugular vein thrombosis or indwelling chronic ports or catheters or presence of vena cava filter
• Subjects with pacemaker or defibrillator leads placed through the SVC ≤ 3 months prior to procedure
• Prior carotid interventions (stenting or endarterectomy)
• Subjects receiving hemodialysis or planning to within 30 days

Other illness

• Active myocardial ischemia (MI) or acute coronary syndrome (ACS)
• Subjects with history of cardiac transplant
• Inability to tolerate right heart catheterization
• Subjects who have a history of major or minor stroke or TIA ≤ 12 months or subjects with a history of stroke \> 12 months who have a residual neurological deficit
• Hypersensitivity or contraindication to latex
• Subjects with history of CABG ≤ 3 months
• Subjects with known coagulopathy or any blood disorders
• Severe carotid disease
• History of DVT (\<6m or requiring ongoing anticoagulants for either DVT or hypercoagulable state)
• History of pulmonary embolism
• Right ventricular failure based on an RA:PCWP ratio of \>0.8, PAPi\<1.0; or TAPSE\<10

Lab values

• Subjects with Ejection Fraction (EF) of \<15%

Other

• Severe valvular stenosis
• Severe aortic valve regurgitation
• Subjects with a contraindication to contrast dye
• Contraindication to unfractionated heparin
• Unable to provide informed consent
• Subjects with impaired decision-making capacity
• Pregnant subjects
• Right atrial/ventricular thrombus
• Sustained ventricular tachycardia (\>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours
• Rapid atrial fibrillation (HR\>120 bpm)
• Systolic blood pressure \< 90 mm Hg
• Inability to interrupt the anticoagulation treatment
• Subjects with life expectancy of \<30 days or known risk for mortality within 90 days
• SVC/IVC stenosis
• SVC/IVC diameter not suitable for balloon inflations
• Planned LVAD device placement
• Subject on \>2 inotropes or escalating inotropes during pre-enrollment hospitalization

• Male or females between 18 and 85 years of age
• NYHA Class III-IV heart failure
• Stage C-D systolic heart failure
• Clinically indicated for right heart catheterization
• Volume overload status of the subject confirmed by the presence of at least 1 or more of the following congestion signs or symptoms assessed by physical examination or x-ray: Peripheral edema, rales, jugular venous distension, abdominal distension or evidence of congestion by chest x-ray
• Subjects with RAP \>10 mmHg
• Subjects with PCWP \>18 mmHg
• Subjects with inadequate diuresis defined as total urinary output over the most recent 8 hours prior to enrollment of \<1200 mL while on a stable dose of diuretics
• Subjects with eGFR \>30mL/min/1.732