[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100394700":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":18,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":18,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Inova Health Care Services","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CardioMEMS Implant Group","EXPERIMENTAL","Following enrollment, patients randomized 1:1 to post-discharge implantation of the CardioMEMS device will receive that device ≤14 days following discharge from the index hospitalization for Cardiogenic Shock, in addition to local standard of care medical therapy.",[13],"Device: CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-CardioMEMS Implant Group","NO_INTERVENTION","Following enrollment, patients randomized 1:1 to post-discharge standard of care will be treated according to local standard of care medical therapy following their index hospitalization for Cardiogenic Shock.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization","Implantation of CardioMEMS Device in patients following admission for Cardiogenic shock, with regular ambulatory pulmonary artery pressure monitoring and medication optimization for the treatment of heart failure.",[9],[26],{"name":27,"affiliation":28,"role":29},"Shashank Sinha, MD MSc","Inova Fairfax Medical Campus","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","7037764001","shashank.sinha@inova.org",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Bhruga Shah, MPH","17037762828","Bhruga.shah@inova.org",[40],{"facility":28,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Falls Church","Virginia","22042","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-77.17109,38.88233,{"lat":51,"lon":50},[54,57,61],{"name":55,"role":32,"phone":56,"phoneExt":18,"email":38},"Bhruga Shah, MS, BSN","703-776-2828",{"name":58,"role":32,"phone":59,"phoneExt":18,"email":60},"Kedir Seid","17037762524","kedir.Seid@inova.org",{"name":27,"role":29,"phone":18,"phoneExt":18,"email":18},{"type":63,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[65],{"name":66,"class":67},"Abbott","INDUSTRY","100394700","hemodynamic-monitoring-to-prevent-adverse-events-following-cardiogenic-shock-trial-100394700",false,"NCT04419480","Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial","HALO-Shock","Inclusion Criteria:\n\n1. Subject or legal representative has signed Informed Consent Form (ICF) and the patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator.\n2. Age ≥ 18 years\n3. NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).\n4. Survive to discharge during a current hospital admission with cardiogenic shock (CS) as defined by clinical criteria previously used in cardiogenic shock trials: systolic blood pressure \\\u003C 90 mmHg for \\> 30 minutes or requiring infusion of catecholamines to maintain the systolic blood pressure above 90 mmHg, with evidence of end-organ dysfunction such as pulmonary edema or impaired end-organ perfusion including altered mentation, oliguria with urine output \\\u003C 30 mL\u002Fh, or serum lactate \\> 2 mmol\u002FL (5). Hemodynamic criteria include cardiac index ≤ 1.8 L\u002Fmin\u002Fm2 without vasoactive pharmacologic agents, or cardiac index ≤ 2.2 L\u002Fmin\u002Fm2 and pulmonary artery occlusion pressure ≥ 15 mmHg with vasoactive agents.\n5. Patients must have internet and phone access (to allow communication of the implanted device with the researchers).\n\nExclusion Criteria:\n\n1. Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.\n2. Treatment with ongoing mechanical circulatory support (MCS) such as a durable left ventricular assist device (LVAD) or recipient of a heart transplantation for the treatment of cardiogenic shock during the index hospitalization for CS.\n3. If of childbearing potential with a positive pregnancy test.\n4. Transition to hospice care.\n5. Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation.\n6. Presence of an active, uncontrolled infection.\n7. Any condition other than heart failure that could limit survival to less than 6 months\n8. Discharge to facility other than acute rehabilitation or to the ambulatory setting.\n9. No access to internet or phone.","ALL","18 Years",{"count":78,"type":79},40,"ESTIMATED","INTERVENTIONAL",[82],"NA","Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock",[85,86,87],"Cardiogenic Shock","Heart Failure","Ambulatory Hemodynamic Monitoring","2026-03-12",{"date":90,"type":91},"2026-03-16","ACTUAL",{"date":93,"type":91},"2020-12-31",{"date":95,"type":79},"2028-12-31",{"name":5,"class":6},1]