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

An Evaluation of the FLOWMod System to Occlude Vena Cava Blood Flow in Subjects With Acute Decompensated Heart Failure

FLOW-HF will assess the impact of intermittent partial occlusion of the SVC and/or IVC, the cardiac filling pressure and the difference of effects between the two occlusion locations (SVC and IVC) using the FlowMod flow modulating device on select parameters in subjects experiencing ADHF (Acute Decompensated Heart Failure)

Intermittent occlusion of the superior vena cava (SVC) and/or inferior vena cava (IVC) might be associated with positive beneficial effects on cardiac filling pressures and improved patient outcomes.

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%