An interventional study of FlowMod System in subjects with acute decompensated heart failure (ADHF) in Acute Decompensated Heart Failure (ADHF), sponsored by FlowMod, Inc.. Not yet recruiting at 4 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by FlowMod, Inc. · Not applicable, Interventional, and Treatment
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 30 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with FlowMod, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male or females between 18 and 85 years of age
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 >30mL/min/1.732
Exclusion Criteria:
Severe valvular stenosis
Severe aortic valve regurgitation
Subjects with a 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
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 ≤ 12 months or subjects with a history of stroke > 12 months who have a residual neurological deficit
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 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 (EF) of \<15%
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant with acute decompensated heart failure (ADHF) while the FlowMod System reduces preloading of the heart.
Device: FlowMod System in subjects with acute decompensated heart failure (ADHF)
The FlowMod System is used in subjects with acute decompensated heart failure (ADHF) for limiting blood flow in the inferior and superior vena cava vessels to the right heart to reduce preloading of the heart.
Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure
Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure defined as: death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke, or prolongation of heart failure-related hospitalization, attributable to the FlowMod device or procedure
Time frame: Through 30 days post procedure
Freedom from primary endpoint MAEs
Defined as: death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke, or prolongation of heart failure-related hospitalization, attributable to the FlowMod device or procedure
Time frame: Through 90 days post procedure
Acute Technical Success
Defined as successful device deployment, ability to intermittently partially occlude the SVC/IVC and successful device removal
Time frame: Immediately after the procedure
Time from device removal to hospital discharge
Time from device removal to hospital discharge will be defined as the elapsed time, in hours, between the documented date and time of complete FlowMod device removal and the documented date and time of discharge from the index hospitalization.
Time frame: Through index discharge, an average of 24 hours
Heart failure-related re-hospitalization rates at 30 and 90 days
defined as any hospital admission occurring after index discharge that is primarily due to worsening signs and/or symptoms of heart failure requiring inpatient treatment.
Time frame: 30 days and 90 days
Re-hospitalization rates (any cause) at 30 and 90 days
Rate of hospital admissions occurring after index discharge for any cause
Time frame: 30 days and 90 days
Urinary spot sodium (3 hours after start of therapy)
Urinary sodium concentration measured in a spot urine sample
Time frame: 3 hours after start of therapy
Weight loss
Change in subject body weight from baseline to protocol-specified post-treatment timepoints
Time frame: From baseline through study completion, an average of 90 days
Time to discharge readiness
Time until the subject is considered clinically ready for safe discharge according to institutional criteria and treating physician assessment.
Time frame: From post-procedure to index discharge, an average of 24 hours
Index admission hemodialysis or continued renal replacement therapy
Occurrence of hemodialysis or continued renal replacement therapy during the index hospitalization following FlowMod therapy.
Time frame: Periprocedural hemodialysis, an average of 24 hours
Hemodialysis post discharge through 90 days post discharge
Occurrence of hemodialysis after index hospital discharge
Time frame: Through 90 days after index discharge
Modified Borg Dyspnea change from baseline, at 12 hours during therapy and post device removal
Change in patient-reported dyspnea severity from baseline, measured using the Modified Borg Dyspnea scale at 12 hours during therapy and after device removal
Time frame: Baseline to 12 hours during therapy and post device removal
Diuretic efficiency changes from baseline, at 12 hours during therapy and post device removal
Diuretic efficiency assessed by urinary output measured in milliliters (mL)
Time frame: At 12 hours and post device removal, an average of 24 hours
EQ5D change from baseline at discharge, 30 and 90 days
Change from baseline in EQ-5D score, a standardized measure of health-related quality of life across mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with self-rated overall health status, assessed at hospital discharge, 30 days, and 90 days.
Time frame: EQ5D from Baseline at discharge, (an average of 24 hours) and at 30 days and 90 days
eGFR change from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first
Change from baseline in estimated glomerular filtration rate (eGFR), calculated based on serum creatinine and used to evaluate renal function, assessed at 24 hours after initiation of FlowMod therapy or at hospital discharge, whichever occurs first.
Time frame: Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first
Cystatin C changes from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first
Change from baseline in Cystatin C, a blood biomarker used to assess kidney function and evaluate changes over time, assessed at 24 hours after initiation of FlowMod therapy or at hospital discharge, whichever occurs first
Time frame: Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first
Right atrial, pulmonary artery, PCWP and cardiac output changes from baseline, at 8 hours during therapy and end of therapy
Change from baseline in invasive hemodynamic parameters, including right atrial pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, and cardiac output, assessed at 8 hours during FlowMod therapy and at end of therapy.
Time frame: Baseline, 8 hours during therapy, and end of therapy
Plan to share: No
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