[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655218":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":83,"studyPopulation":76,"armGroups":84,"interventions":91,"overallOfficials":76,"centralContacts":96,"locations":102,"responsibleParty":135,"collaborators":76,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":139,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":76,"studyType":151,"phases":152,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":160,"whyStopped":76,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"FlowMod, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":76},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,22,26,30,33,37,41,45,49,53,57,61,65,69,72],{"measure":15,"description":16,"timeFrame":17},"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",{"measure":19,"description":20,"timeFrame":21},"Acute Technical Success","Defined as successful device deployment, ability to intermittently partially occlude the SVC\u002FIVC and successful device removal","Immediately after the procedure",{"measure":23,"description":24,"timeFrame":25},"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",{"measure":27,"description":28,"timeFrame":29},"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\u002For symptoms of heart failure requiring inpatient treatment.","30 days and 90 days",{"measure":31,"description":32,"timeFrame":29},"Re-hospitalization rates (any cause) at 30 and 90 days","Rate of hospital admissions occurring after index discharge for any cause",{"measure":34,"description":35,"timeFrame":36},"Urinary spot sodium (3 hours after start of therapy)","Urinary sodium concentration measured in a spot urine sample","3 hours after start of therapy",{"measure":38,"description":39,"timeFrame":40},"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",{"measure":42,"description":43,"timeFrame":44},"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",{"measure":46,"description":47,"timeFrame":48},"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",{"measure":50,"description":51,"timeFrame":52},"Hemodialysis post discharge through 90 days post discharge","Occurrence of hemodialysis after index hospital discharge","Through 90 days after index discharge",{"measure":54,"description":55,"timeFrame":56},"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",{"measure":58,"description":59,"timeFrame":60},"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",{"measure":62,"description":63,"timeFrame":64},"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\u002Fdiscomfort, and anxiety\u002Fdepression, 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",{"measure":66,"description":67,"timeFrame":68},"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",{"measure":70,"description":71,"timeFrame":68},"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",{"measure":73,"description":74,"timeFrame":75},"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",null,{"allocation":78,"interventionModel":79,"interventionModelDescription":76,"primaryPurpose":80,"observationalModel":76,"timePerspective":76,"maskingInfo":81},"NA","SINGLE_GROUP","TREATMENT",{"masking":82,"maskingDescription":76,"whoMasked":76},"NONE","Intermittent occlusion of the superior vena cava (SVC) and\u002For inferior vena cava (IVC) might be associated with positive beneficial effects on cardiac filling pressures and improved patient outcomes.",[85],{"label":86,"type":87,"description":88,"interventionNames":89},"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.",[90],"Device: FlowMod System in subjects with acute decompensated heart failure (ADHF)",[92],{"type":93,"name":86,"description":94,"armGroupLabels":95,"otherNames":76},"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.",[86],[97],{"name":98,"role":99,"phone":100,"phoneExt":76,"email":101},"Jean-Maurice Dussartre, MD","CONTACT","+33672926156","jm.dussartre@flow-mod.com",[103,115,120,130],{"facility":104,"status":76,"city":105,"state":76,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":76},"Tbilisi Heart Center","Tbilisi","0186","Georgia","GE",{"type":110,"coordinates":111},"Point",[112,113],44.83412,41.69143,{"lat":113,"lon":112},{"facility":116,"status":76,"city":105,"state":76,"zip":76,"country":107,"countryCode":108,"cosmosGeoPoint":117,"geoPoint":119,"contacts":76},"Tbilisi Heart And Vascular Clinic",{"type":110,"coordinates":118},[112,113],{"lat":113,"lon":112},{"facility":121,"status":76,"city":122,"state":76,"zip":76,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":129,"contacts":76},"Ezgu Niyat Medical Clinic","Tashkent","Uzbekistan","UZ",{"type":110,"coordinates":126},[127,128],69.21627,41.26465,{"lat":128,"lon":127},{"facility":131,"status":76,"city":122,"state":76,"zip":76,"country":123,"countryCode":124,"cosmosGeoPoint":132,"geoPoint":134,"contacts":76},"Republican Specialized Center of Cardiology",{"type":110,"coordinates":133},[127,128],{"lat":128,"lon":127},{"type":136,"investigatorFullName":76,"investigatorTitle":76,"investigatorAffiliation":76,"oldNameTitle":76,"oldOrganization":76},"SPONSOR","100655218","evaluation-of-flowmod-system-while-intermittently-partially-occluding-vena-cava-blood-flow-in-subjects-with-adhf-100655218",false,"NCT07810335","Evaluation of FlowMod System While Intermittently Partially Occluding Vena Cava Blood Flow in Subjects With ADHF","An Evaluation of the FLOWMod System to Occlude Vena Cava Blood Flow in Subjects With Acute Decompensated Heart Failure","FLOW-HF","Inclusion Criteria:\n\nMale or females between 18 and 85 years of age\n\nNYHA Class III-IV heart failure\n\nStage C-D systolic heart failure\n\nClinically indicated for right heart catheterization\n\nVolume 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\n\nSubjects with RAP \\>10 mmHg\n\nSubjects with PCWP \\>18 mmHg\n\nSubjects with inadequate diuresis defined as total urinary output over the most recent 8 hours prior to enrollment of \\\u003C1200 mL while on a stable dose of diuretics\n\nSubjects with eGFR \\>30mL\u002Fmin\u002F1.732\n\nExclusion Criteria:\n\nSevere valvular stenosis\n\nSevere aortic valve regurgitation\n\nSubjects with a contraindication to contrast dye\n\nActive myocardial ischemia (MI) or acute coronary syndrome (ACS)\n\nACS or MI within 30 days prior to enrollment\n\nContraindication to unfractionated heparin\n\nUnable to provide informed consent\n\nSubjects with impaired decision-making capacity\n\nSubjects receiving mechanical circulatory support\n\nSubjects with history of cardiac transplant\n\nPregnant subjects\n\nRight atrial\u002Fventricular thrombus\n\nSubjects with inadequate jugular vein access due to prior jugular vein thrombosis or indwelling chronic ports or catheters or presence of vena cava filter\n\nInability to tolerate right heart catheterization\n\nSubjects 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\n\nHypersensitivity or contraindication to latex\n\nSustained ventricular tachycardia (\\>10 beats) within 24 hours and\u002For ventricular fibrillation within 24 hours\n\nSubjects with history of CABG ≤ 3 months\n\nSubjects with pacemaker or defibrillator leads placed through the SVC ≤ 3 months prior to procedure\n\nRapid atrial fibrillation (HR\\>120 bpm)\n\nSystolic blood pressure \\\u003C 90 mm Hg\n\nInability to interrupt the anticoagulation treatment\n\nSubjects with known coagulopathy or any blood disorders\n\nSubjects with life expectancy of \\\u003C30 days or known risk for mortality within 90 days\n\nPrior carotid interventions (stenting or endarterectomy)\n\nSevere carotid disease\n\nHistory of DVT (\\\u003C6m or requiring ongoing anticoagulants for either DVT or hypercoagulable state)\n\nHistory of pulmonary embolism\n\nSVC\u002FIVC stenosis\n\nSVC\u002FIVC diameter not suitable for balloon inflations\n\nSubjects receiving hemodialysis or planning to within 30 days\n\nPlanned LVAD device placement\n\nSubject on \\>2 inotropes or escalating inotropes during pre-enrollment hospitalization\n\nRight ventricular failure based on an RA:PCWP ratio of \\>0.8, PAPi\\\u003C1.0; or TAPSE\\\u003C10\n\nSubjects with Ejection Fraction (EF) of \\\u003C15%","ALL","18 Years","85 Years",{"count":149,"type":150},30,"ESTIMATED","INTERVENTIONAL",[78],"FLOW-HF will assess the impact of intermittent partial occlusion of the SVC and\u002For 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)",[155],"Acute Decompensated Heart Failure (ADHF)",[157,158,159],"intermittent partial occlusion","inferior vena cava","superior vena cava","NOT_YET_RECRUITING","2026-09-03",{"date":163,"type":164},"2026-09-09","ACTUAL",{"date":166,"type":150},"2026-09-05",{"date":168,"type":150},"2027-05-15",{"name":5,"class":6},4]