Health Trials

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

ConditionAcute Decompensated Heart Failure (ADHF)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFlowMod, Inc.

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: FlowMod System in subjects with acute decompensated heart failure (ADHF)Experimental treatment 1 intervention

Trial outcomes

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

Time frame
Through 30 days post procedure

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

FlowMod, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: