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

NCT07810335 | Not Yet Recruiting

• 1 other identifier: CP1207
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 4

Brief 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 Failure)

Conditions

Acute Decompensated Heart Failure (ADHF)

Keywords

intermittent partial occlusion; inferior vena cava; superior vena cava

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Freedom from primary endpoint MAEs

  Through 90 days post procedure

• Acute Technical Success

  Immediately after the procedure

• Time from device removal to hospital discharge

  Through index discharge, an average of 24 hours

• Heart failure-related re-hospitalization rates at 30 and 90 days

  30 days and 90 days

• Re-hospitalization rates (any cause) at 30 and 90 days

  30 days and 90 days

Study Arms (1)

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.

Device: FlowMod System in subjects with acute decompensated heart failure (ADHF)

Interventions

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.

FlowMod System in subjects with acute decompensated heart failure (ADHF)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FlowMod, Inc.: lead

Study Sites (4)

Tbilisi Heart Center

Tbilisi, 0186, Georgia

Location

Tbilisi Heart And Vascular Clinic

Tbilisi, Georgia

Location

Ezgu Niyat Medical Clinic

Tashkent, Uzbekistan

Location

Republican Specialized Center of Cardiology

Tashkent, Uzbekistan

Location

Central Study Contacts

Jean-Maurice Dussartre, MD

CONTACT

+33672926156; jm.dussartre@flow-mod.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 9, 2026
• Study Start: September 5, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GE (2); UZ (2)