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FlowMod System in subjects with acute decompensated heart failure (ADHF) / Acute Decompensated Heart Failure (ADHF) · Interventional Study
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered early-stage device study in acute decompensated heart failure designed to evaluate the FlowMod System for safety and effects on cardiac filling pressure through partial vena caval occlusion. No results are posted in this registry record; the study has not yet begun recruitment. The primary outcome is freedom from device- or procedure-related major adverse events at 30 days.
Interventional, Single Group, Open label, Treatment purpose. Acute Decompensated Heart Failure (ADHF); age from 18 Years; to 85 Years. Intervention: FlowMod System in subjects with acute decompensated heart f…. n = 30. 4 sites: Georgia, Uzbekistan.
This is a registered early-stage device study in acute decompensated heart failure designed to evaluate the FlowMod System for safety and effects on cardiac filling pressure through partial vena caval occlusion. No results are posted in this registry record; the study has not yet begun recruitment. The primary outcome is freedom from device- or procedure-related major adverse events at 30 days.
Primary outcome is safety only; clinical efficacy endpoints not stated in registry summary. Sample size of 30 is small and may be insufficient for reliable safety and efficacy inference.
This registry record describes a planned safety and mechanistic study with no clinical outcomes yet assessed. Clinicians should not draw conclusions about efficacy or safety until results are published.
This is a registered interventional device study in planning phase with no results posted; it is designed to assess safety and mechanistic parameters in a small cohort with acute heart failure.
As stated by the source record.
Quoted from the source exactly as published.
This registry record describes a planned safety and mechanistic study with no clinical outcomes yet assessed. Clinicians should not draw conclusions about efficacy or safety until results are published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07810335). This is a study registration, not published results. Lead sponsor: FlowMod, Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Acute Decompensated Heart Failure (ADHF). Interventions: DEVICE: FlowMod System in subjects with acute decompensated heart failure (ADHF). Primary outcome measures: Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure , Through 30 days post procedure. 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)
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.