[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"FlowMod, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","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)",[28],"Acute Decompensated Heart Failure (ADHF)",[30,31,32],"intermittent partial occlusion","inferior vena cava","superior vena cava","NOT_YET_RECRUITING","2026-09-03",{"date":36,"type":37},"2026-09-09","ACTUAL",{"date":39,"type":22},"2026-09-05",{"date":41,"type":22},"2027-05-15",{"name":43,"class":44},"FlowMod, Inc.","INDUSTRY",4,""]