[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06779552":3,"trial-entities:NCT06779552":71,"trial-summary:NCT06779552":74},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":14,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":32,"secondary_outcomes":37,"sex":41,"minimum_age":42,"maximum_age":14,"healthy_volunteers":14,"eligibility_criteria":43,"std_ages":47,"locations":50,"central_contacts":66,"overall_officials":68,"references":69,"see_also_links":70},"NCT06779552","CL1027482","CardioMEMS HF System Coverage With Evidence Development Study","RECRUITING","2032-03","2026-03","2026-04-03","2025-02-07","Abbott Medical Devices","INDUSTRY",null,"The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.","The CardioMEMS CED Study will assess 2-year HF hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the CardioMEMS HF system, as compared to a contemporaneous control of HF subjects managed without PA pressure-guidance.",[18],"Heart Failure",[],"OBSERVATIONAL",[],{"count":23,"type":24},1000,"ESTIMATED",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30},"DEVICE","CardioMEMS HF System","PA Pressure Sensor",[31],"Treatment Group",[33],{"measure":34,"description":35,"timeFrame":36},"HF Hospitalization Rate.","Compare HF hospitalization rate between the treatment and control groups.","2 years",[38],{"measure":39,"description":40,"timeFrame":36},"Two-Year Survival","Compare survival between the treatment and control groups.","ALL","18 Years",{"inclusion":44,"exclusion":45,"raw_text":46},[],[],"Inclusion Criteria:\n\n1. Subject implanted with a CardioMEMS pressure sensor (treatment arm only)\n2. Subject \\>=18 years of age at time of implant\n3. Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitalization, elevated BNP\u002FNT-proBNP\n\nExclusion Criteria:\n\n1. Subject has history of heart transplant or durable mechanical circulatory device\n2. Subject hospitalized with cardiogenic shock or sepsis\n3. Subject received prior PA pressure sensor implant (control arm only)",[48,49],"ADULT","OLDER_ADULT",[51],{"facility":52,"status":7,"city":53,"state":54,"zip":55,"country":56,"contacts":57,"geoPoint":63},"Abbott","Pleasanton","California","94588","United States",[58],{"name":59,"role":60,"phone":61,"email":62},"Nessa Johnson","CONTACT","612-283-3865","nessa.johnson@abbott.com",{"lat":64,"lon":65},37.66243,-121.87468,[67],{"name":59,"role":60,"phone":61,"email":62},[],[],[],{"nct_id":4,"conditions":72,"biomarkers":73},[18],[],{"nct_id":4,"found":75,"summary":76,"prompt_version":86},true,{"design":77,"status":78,"heading":79,"summary":80,"follow_up":81,"word_count":82,"commitments":83,"compensation":84,"drugs_mentioned":85},"This is an observational study comparing heart failure patients managed with the CardioMEMS HF system to a group managed without it. It is not specified if this study is randomized or blinded.","completed","CardioMEMS HF System Study for Heart Failure","This study is looking at how well the CardioMEMS HF System helps people with heart failure in real-world settings. The CardioMEMS HF System is a device that measures pressure in your pulmonary artery (the main artery from your heart to your lungs). Researchers want to see if using this system to guide heart failure treatment improves long-term health, specifically by reducing how often people need to be hospitalized for heart failure. You might be able to join if you are 18 or older, have a CardioMEMS pressure sensor implanted, and have a history of acute decompensated heart failure or heart failure-related congestion. The study aims to enroll 1000 participants, but its current status is unclear.","The study will assess outcomes for 2 years.",115,"Not specified in the trial record.","Not stated in the trial record.",[28],"v2"]