[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Reprieve Cardiovascular, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100537046","reprieve-system-pilot-study-100537046",false,"NCT06272734","Reprieve System Pilot Study","Reprieve System for the Treatment of Subjects With Acute Decompensated Heart Failure Pilot Study","Inclusion Criteria:\n\n1. Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema\u002Fswelling) AND 1 sign (peripheral edema, ascites, jugular venous distension, pulmonary vascular congestion on chest radiography)\n2. ≥10 lb. (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.\n3. Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. Inability to place Foley catheter or IV catheter or other urologic issues that would predispose the patient to a high rate of urogenital trauma or infection with catheter placement.\n2. Hemodynamic instability as defined by any of the following: systolic blood pressure \\\u003C90 mmHg, use of vasopressors, use of IV inotropes to treat hypotension (systolic blood pressure \\\u003C90 mm Hg) or suspected\u002Fconfirmed low cardiac output\u002Fshock, mechanical circulatory support, uncontrolled arrhythmias, active severe bleeding, or confirmed or suspected cardiogenic shock. Note: In the absence of the above conditions, use of inotropes to augment diuresis is permitted.\n3. Dyspnea due primarily to non-cardiac causes (e.g., severe chronic obstructive pulmonary disease or pneumonia).\n4. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).\n5. Estimated glomerular filtration rate (eGFR) \\\u003C 20 ml\u002Fmin\u002F1.73m2 calculated using the MDRD equation or current use of renal replacement therapy (RRT).\n6. Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, known severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment (within previous week), or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.\n7. Inability to follow instructions or comply with follow-up procedures.\n8. Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the protocol instructions or follow-up procedures.\n9. Severe baseline electrolyte abnormalities (e.g., serum potassium \\\u003C3.0 mEq\u002FL or magnesium \\\u003C1.3 mEq\u002FL). Note: These are based on baseline\u002Fscreening labs. Subjects whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial.\n10. Serum sodium \\\u003C135 mmol\u002FL or history of severe hyponatremia\n11. Poorly controlled diabetes\n12. Enrollment in another interventional trial during the index hospitalization\n13. Life expectancy less than 3 months\n14. Women who are pregnant or intend to become pregnant.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure.",[26],"Acute Decompensated Heart Failure","RECRUITING","2026-02-03",{"date":30,"type":31},"2026-02-05","ACTUAL",{"date":33,"type":31},"2024-01-23",{"date":35,"type":20},"2026-12-31",{"name":37,"class":38},"Reprieve Cardiovascular, Inc","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100585142","phase-3-fluid-management-of-acute-decompensated-heart-failure-subjects-treated-with-reprieve-system-fastr-ii-ide-g210258-100585142","NCT06898515","Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)","Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II)","FASTR-II","Inclusion Criteria:\n\n1. Diagnosis of HF with expected hospitalization \\>24 hours, with \\>1 new or worsening symptom and \\>2 physical examination, laboratory, or invasive findings of HF, and receiving or with plans to receive a HF-specific treatment\n2. ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider.\n3. Current outpatient prescription for daily loop diuretic.\n4. Participants ≥ 22 years of age able to provide informed consent and comply with study procedures.\n5. Elevated risk of diuretic resistance, as indicated by at least one of the following: Baseline hypochloremia OR Urine output \\\u003C1L in the 6 hours following IV loop diuretic \\>=40 mg furosemide equivalent OR Spot urine sodium \\\u003C100 mmol\u002FL 1-2 hours after IV loop diuretic \\>= 40 mg furosemide equivalent\n\nExclusion Criteria:\n\n1. Urologic issues that would predispose the participant to a high rate of urogenital trauma or infection with catheter placement or known inability to place a Foley catheter.\n2. Hemodynamic instability as defined by any of the following: sustained systolic blood pressure \\\u003C90 mmHg for \\>15 minutes within the past 48 hours, use of IV vasopressors or inotropes within past 48 hours, and\u002For current or previous mechanical circulatory support within the last week.\n3. Uncontrolled arrhythmias defined as sustained HR \\>130 beats\u002Fmin for \\>10 minutes within the past 48 hours.\n4. Severe lung disease with chronic home oxygen requirement \\>2L\u002Fmin.\n5. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).\n6. Estimated glomerular filtration rate (eGFR) \\\u003C25 ml\u002Fmin\u002F1.73m2 (calculated with either MDRD or CKD-EPI) or current use of renal replacement therapy (RRT).\n7. Significant left ventricular outflow obstruction, severe uncorrected complex congenital heart disease, known severe stenotic valvular disease, severe infiltrative or constrictive cardiomyopathy or other diagnosis that would make aggressive decongestion unsafe.\n8. Current or recent (\\\u003C 30 days) type I myocardial infarction (e.g., acute coronary syndrome such as NSTEMI or STEMI from plaque rupture), coronary artery bypass surgery, or stroke. An isolated troponin elevation (e.g., from volume overload or demand ischemia) is not a reason for exclusion.\n9. Severe electrolyte abnormalities (e.g., serum potassium \\\u003C3.0 mEq\u002FL, magnesium \\\u003C1.3 mEq\u002FL or sodium \\\u003C125 mEq\u002FL). Note: These are based on baseline\u002Fscreening labs. Participants whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial.\n10. Other concomitant disease or condition the investigator believes will make it difficult to follow instructions or comply with study procedures and\u002For follow-up visits, including expected prolonged hospitalization for reasons other than decongestive therapy\n11. Currently enrolled in an interventional trial (observational studies are permitted).\n12. Life expectancy less than 6 months.\n13. Women who are pregnant or breastfeeding.","22 Years",{"count":50,"type":20},400,[52],"PHASE3","The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve System to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve System can more efficiently decongest ADHF patients in comparison to Control Therapy.",[26],"2025-11-24",{"date":57,"type":31},"2025-11-26",{"date":59,"type":31},"2025-07-14",{"date":61,"type":20},"2027-12",{"name":37,"class":38},53,""]