Acute Decompensated Heart Failure (ADHF)
Conditions
Keywords
intermittent partial occlusion, inferior vena cava, superior vena cava
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)
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.
Interventions
DEVICEFlowMod 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.
Sponsors
FlowMod, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from primary endpoint MAEs | Through 90 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 |
| Acute Technical Success | Immediately after the procedure | Defined as successful device deployment, ability to intermittently partially occlude the SVC/IVC and successful device removal |
| Time from device removal to hospital discharge | Through index discharge, an average of 24 hours | 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. |
| Heart failure-related re-hospitalization rates at 30 and 90 days | 30 days 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. |
| Re-hospitalization rates (any cause) at 30 and 90 days | 30 days and 90 days | Rate of hospital admissions occurring after index discharge for any cause |
| Urinary spot sodium (3 hours after start of therapy) | 3 hours after start of therapy | Urinary sodium concentration measured in a spot urine sample |
| Weight loss | From baseline through study completion, an average of 90 days | Change in subject body weight from baseline to protocol-specified post-treatment timepoints |
| Time to discharge readiness | From post-procedure to index discharge, an average of 24 hours | Time until the subject is considered clinically ready for safe discharge according to institutional criteria and treating physician assessment. |
| Index admission hemodialysis or continued renal replacement therapy | Periprocedural hemodialysis, an average of 24 hours | Occurrence of hemodialysis or continued renal replacement therapy during the index hospitalization following FlowMod therapy. |
| Hemodialysis post discharge through 90 days post discharge | Through 90 days after index discharge | Occurrence of hemodialysis after index hospital discharge |
| Modified Borg Dyspnea change from baseline, at 12 hours during therapy and post device removal | Baseline to 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 |
| Diuretic efficiency changes from baseline, at 12 hours during therapy and post device removal | At 12 hours and post device removal, an average of 24 hours | Diuretic efficiency assessed by urinary output measured in milliliters (mL) |
| EQ5D change from baseline at discharge, 30 and 90 days | EQ5D from Baseline at discharge, (an average of 24 hours) and at 30 days 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. |
| eGFR change from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first | Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs 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. |
| Cystatin C changes from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first | Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs 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 |
| Right atrial, pulmonary artery, PCWP and cardiac output changes from baseline, at 8 hours during therapy and end of therapy | Baseline, 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. |
Countries
Georgia, Uzbekistan
Contacts
CONTACTJean-Maurice Dussartre, MD
Outcome results
None listed