[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576287":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":17,"centralContacts":21,"locations":30,"responsibleParty":45,"collaborators":7,"id":47,"slug":7,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":7,"enrollmentInfo":56,"targetDuration":7,"studyType":59,"phases":7,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":33,"whyStopped":7,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Endotronix, Inc.","INDUSTRY",null,[9,13],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Cordella PA Sensor System","* Patients who receive the Cordella PA Sensor System for monitoring chronic heart failure\n* These patients will be monitored for 2 years after receiving the device\n* Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status",{"type":14,"name":15,"description":16,"armGroupLabels":7,"otherNames":7},"DRUG","Standard of Care Pharmacologic Therapy","* Patients with chronic heart failure who receive standard medical care without PA pressure monitoring\n* These patients will be monitored for 2 years\n* Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status",[18],{"name":19,"affiliation":5,"role":20},"Joanna VanHouten, PhD","PRINCIPAL_INVESTIGATOR",[22,27],{"name":23,"role":24,"phone":25,"phoneExt":7,"email":26},"Andrea Sauerland","CONTACT","630-599-7176","andrea_sauerland@edwards.com",{"name":28,"role":24,"phone":7,"phoneExt":7,"email":29},"Max Gill","max_gill@edwards.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":7},"Endotronix","RECRUITING","Naperville","Illinois","60563","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-88.14729,41.78586,{"lat":43,"lon":42},{"type":46,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100576287",false,"NCT06783335","Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure","The Real-World Effectiveness of The Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Failure: A Comparative Analysis to Standard of Care Pharmacologic Therapy","LOWER-PAP","Inclusion Criteria for Cordella PA Sensor System Cohort:\n\n* Received Cordella PA Sensor System implant between 10\u002F1\u002F2024-12\u002F31\u002F2029\n* Documented chronic heart failure with NYHA Class III symptoms\n* On guideline-directed medical therapy based on ejection fraction status:\n\n  * For reduced EF (≤40%): At least one fill of ACE\u002FARB\u002FARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic\n  * For preserved EF (\\>40%): At least one fill of a loop diuretic\n* Has continuous health insurance enrollment for 12 months prior to implant\n\nInclusion Criteria for Standard of Care Control Cohort:\n\n* Two or more encounters with diagnosis codes for chronic systolic and\u002For diastolic heart failure\n* Documented ejection fraction reading within 6 months (+ or -) of second heart failure encounter\n* On guideline-directed medical therapy based on ejection fraction status:\n\n  * For reduced EF (≤40%): At least one fill of ACE\u002FARB\u002FARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic\n  * For preserved EF (\\>40%): At least one fill of a loop diuretic\n* Has continuous health insurance enrollment for 12 months prior to study entry\n\nExclusion Criteria:\n\n* No implanted pulmonary artery sensor or monitoring at any time (Standard of Care Control Cohort only)\n* Record of temporary mechanical circulatory support during baseline period\n* Diagnosis of cardiogenic shock during baseline period\n* Receiving palliative care\u002Fhospice during baseline period\n* Record of end-stage renal disease during baseline period\n* Unable to take dual antiplatelet therapy or anticoagulants for one month post implant (Cordella Cohort only)","ALL","18 Years",{"count":57,"type":58},2150,"ESTIMATED","OBSERVATIONAL","This retrospective, non-randomized cohort study will evaluate how well the Cordella PA Sensor System works compared to standard medication treatment in people with chronic heart failure. The study will track patients for two years to see if those using the Cordella system have fewer deaths and hospitalizations related to heart failure.",[62,63],"Heart Failure NYHA Class III","Heart Failure",[65,66,67,68,69],"Heart failure","Heart Disease","Pulmonary Artery Pressure Sensor","Cardiovascular Disease","Cordella","2025-11-18",{"date":72,"type":73},"2025-11-19","ACTUAL",{"date":75,"type":73},"2025-02-07",{"date":77,"type":58},"2030-12-31",{"name":5,"class":6},1]