Acute Decompensated Heart Failure (ADHF)FLOW-HFNCT07810335
Evaluation of FlowMod System While Intermittently Partially Occluding Vena Cava Blood Flow in Subjects With ADHF
A study testing FlowMod System in subjects with acute decompensated heart failure (ADHF) in people with Acute Decompensated Heart Failure (ADHF), run by FlowMod, Inc. at 4 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Decompensated Heart Failure (ADHF)
- What is being tested?
- FlowMod System in subjects with acute decompensated heart failure (ADHF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 5 Sep 2026to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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%
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Georgia2 sites
Tbilisi Heart Center
Tbilisi, 0186
Tbilisi Heart And Vascular Clinic
Tbilisi
Uzbekistan2 sites
Ezgu Niyat Medical Clinic
Tashkent
Republican Specialized Center of Cardiology
Tashkent
About this study
Official title: 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)
Read the detailed description
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.
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Being tested
- FlowMod System in subjects with acute decompensated heart failure (ADHF)
- Keywords
- intermittent partial occlusion, inferior vena cava, superior vena cava
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowMod System in subjects with acute decompensated heart failure (ADHF)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| FlowMod System in subjects with acute decompensated heart failure (ADHF) | Experimental | Participant with acute decompensated heart failure (ADHF) while the FlowMod System reduces preloading of the heart. Receives: Device: FlowMod System in subjects with acute decompensated heart failure (ADHF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through 30 days post procedure
Secondary outcomes (16)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 30 days and 90 days
Urinary spot sodium (3 hours after start of therapy)
Urinary sodium concentration measured in a spot urine sample
Measured: 3 hours after start of therapy
Weight loss
Change in subject body weight from baseline to protocol-specified post-treatment timepoints
Measured: 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.
Measured: 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.
Measured: Periprocedural hemodialysis, an average of 24 hours
Hemodialysis post discharge through 90 days post discharge
Occurrence of hemodialysis after index hospital discharge
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, 8 hours during therapy, and end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start5 Sep 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart Failure (ADHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FlowMod, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810335
- Sponsor's protocol ID
- CP1207
- Acronym
- FLOW-HF
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the FLOWMod System to Occlude Vena Cava Blood Flow in Subjects With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07810335
- Acronym / sponsor ID
- FLOW-HF / CP1207
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Keywords
- intermittent partial occlusion, inferior vena cava, superior vena cava
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- FlowMod, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FlowMod System in subjects with acute decompensated heart failure (ADHF) | Experimental | Device: FlowMod System in subjects with acute decompensated heart failure (ADHF)Participant with acute decompensated heart failure (ADHF) while the FlowMod System reduces preloading of the heart. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | FlowMod System in subjects with acute decompensated heart failure (ADHF) |
Primary outcome
Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure
Time frame: 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
16 secondary outcomes
Freedom from primary endpoint MAEs
Time frame: Through 90 days post procedure
Acute Technical Success
Time frame: Immediately after the procedure
Time from device removal to hospital discharge
Time frame: Through index discharge, an average of 24 hours
Heart failure-related re-hospitalization rates at 30 and 90 days
Time frame: 30 days and 90 days
Re-hospitalization rates (any cause) at 30 and 90 days
Time frame: 30 days and 90 days
Urinary spot sodium (3 hours after start of therapy)
Time frame: 3 hours after start of therapy
Weight loss
Time frame: From baseline through study completion, an average of 90 days
Time to discharge readiness
Time frame: From post-procedure to index discharge, an average of 24 hours
Index admission hemodialysis or continued renal replacement therapy
Time frame: Periprocedural hemodialysis, an average of 24 hours
Hemodialysis post discharge through 90 days post discharge
Time frame: Through 90 days after index discharge
Modified Borg Dyspnea change from baseline, at 12 hours during therapy and post 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
Time frame: At 12 hours and post device removal, an average of 24 hours
EQ5D change from baseline at discharge, 30 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
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
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
Time frame: Baseline, 8 hours during therapy, and end of therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlowMod System in subjects with acute decompensated heart failure (ADHF) in people with Acute Decompensated Heart Failure (ADHF), run by FlowMod, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Georgia, Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Maurice Dussartre, MD (+33672926156, jm.dussartre@flow-mod.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure (time frame: Through 30 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.