Evaluation of FlowMod System While Intermittently Partially Occluding Vena Cava Blood Flow in Subjects With ADHF (FLOW-HF)

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Decompensated Heart Failure (ADHF)
• Intervention / Treatment: Device: FlowMod System in subjects with acute decompensated heart failure (ADHF)

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Maurice Dussartre, MD; Phone Number: +33672926156; Email: jm.dussartre@flow-mod.com

Study Locations

• Georgia
  • Tbilisi, Georgia, 0186
    • Tbilisi Heart Center
  • Tbilisi, Georgia
    • Tbilisi Heart And Vascular Clinic
• Uzbekistan
  • Tashkent, Uzbekistan
    • Ezgu Niyat Medical Clinic
  • Tashkent, Uzbekistan
    • Republican Specialized Center of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through 30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	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	30 days and 90 days
Urinary spot sodium (3 hours after start of therapy)	Urinary sodium concentration measured in a spot urine sample	3 hours after start of therapy
Weight loss	Change in subject body weight from baseline to protocol-specified post-treatment timepoints	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.	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.	Periprocedural hemodialysis, an average of 24 hours
Hemodialysis post discharge through 90 days post discharge	Occurrence of hemodialysis after index hospital discharge	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	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)	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.	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.	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	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.	Baseline, 8 hours during therapy, and end of therapy

Collaborators and Investigators

• Sponsor: FlowMod, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): September 5, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): May 15, 2027

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: inferior vena cava; superior vena cava; intermittent partial occlusion
• Other Study ID Numbers: CP1207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No