An evaluation of the FLOWMod system to occlude vena cava blood flow in subjects with acute decompensated heart failure

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Exclusion Criteria: Severe valvular stenosis Severe aortic valve regurgitation Subjects with a contraindication to contrast dye Active myocardial ischemia (MI) or acute coronary syndrome (ACS) ACS or MI within 30 days prior to enrollment Contraindication to unfractionated heparin Unable to provide informed consent Subjects with impaired decision-making capacity Subjects receiving mechanical circulatory support Subjects with history of cardiac transplant Pregnant subjects Right atrial/ventricular thrombus Subjects with inadequate jugular vein access due to prior jugular vein thrombosis or indwelling chronic ports or catheters or presence of vena cava filter 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 Sustained ventricular tachycardia (\>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours Subjects with history of CABG ≤ 3 months Subjects with pacemaker or defibrillator leads placed through the SVC ≤ 3 months prior to procedure Rapid atrial fibrillation (HR\>120 bpm) Systolic blood pressure \< 90 mm Hg Inability to interrupt the anticoagulation treatment Subjects with known coagulopathy or any blood disorders Subjects with life expectancy of \<30 days or known risk for mortality within 90 days Prior carotid interventions (stenting or endarterectomy) Severe carotid disease History of DVT (\<6m or requiring ongoing anticoagulants for either DVT or hypercoagulable state) History of pulmonary embolism SVC/IVC stenosis SVC/IVC diameter not suitable for balloon inflations Subjects receiving hemodialysis or planning to within 30 days Planned LVAD device placement Subject on \>2 inotropes or escalating inotropes during pre-enrollment hospitalization Right ventricular failure based on an RA:PCWP ratio of \>0.8, PAPi\<1.0; or TAPSE\<10 Subjects with Ejection Fraction (EF) of \<15%