FlowMod device partly narrows large veins in people with acute heart failure

Trial details

Who runs it

FlowMod, Inc.

Trial code

NCT07810335

Record updated

9 September 2026

Original description

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)Read full original descriptionShow less

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)

Inclusion: 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: 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; 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; Subjects with Ejection Fraction (EF) of <15%; 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.

ClinicalTrials.gov NCT07810335