[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609018":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":29,"responsibleParty":45,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Impulse Dynamics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group",null,"Treatment patients shall be those with a clinical indication for CCM implantation according to FDA approved labeling and who are implanted with the Optimizer System.",[13],"Device: Cardiac Contractility Modulation (CCM)",{"label":15,"type":10,"description":16,"interventionNames":10},"Control Group","The control group shall be derived from propensity score matching of patients derived from the database with a clinical indication for CCM implantation who do not receive an implant.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DEVICE","Cardiac Contractility Modulation (CCM)","CCM is a therapy delivered via the Optimizer System, which is implanted in eligible heart failure patients. The device delivers non-excitatory electrical signals to the heart during the absolute refractory period, enhancing the strength of cardiac contractions without increasing myocardial oxygen consumption.",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Kathy Sherwood, MBA","CONTACT","856-642-9933","ksherwood@impulsedynamics.com",[30],{"facility":5,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Marlton","New Jersey","08053","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-74.92183,39.89122,{"lat":41,"lon":40},[44],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},{"type":46,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100609018","propensity-matched-study-of-cardiac-contractility-modulation-therapy-in-heart-failure-100609018",false,"NCT07209098","Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure","Broaden Accessibility of Breakthrough Treatment for Heart Failure: A Prospective, Propensity-Matched CED to Access the Impact of Cardiac Contractility Modulation Therapy (CCM)","BRIGHTEN-HF","Inclusion Criteria\n\n1. Continuous representation in the database in the year prior to index.\n2. Age 18 or older will be enrolled in either the treatment or control arm of the study.\n3. NYHA III heart failure,\n4. Not receiving CRT\n5. EF 25 - 45%, inclusive.\n6. Remain symptomatic despite at least 3 months of optimized guideline-directed medical therapy (GDMT) as determined by the heart team prior to CCM implantation.\n\nExclusion Criteria\n\n1. Subject has had a prior heart transplant\n2. Subject with mechanical tricuspid valve.\n3. Subject has a left ventricular assist device (LVAD).","ALL","18 Years",{"count":58,"type":59},4200,"ESTIMATED","OBSERVATIONAL","The purpose of this prospective, multi-center, propensity-matched coverage with evidence development (CED) study is to assess the impact of cardiac contractility modulation (CCM) on mortality and heart failure hospitalizations in Medicare-eligible patients with heart failure who meet indications for CCM.",[63,64],"Heart Failure and Reduced Ejection Fraction","NYHA Class III Heart Failure",[66,67,68,69,70,71,72,73,74],"Heart failure","Reduced ejection fraction","Cardiac Contractility Modulation","CCM","NYHA III","Propensity Score Matching","All-Cause Mortality","Heart Failure Hospitalizations","CED","2026-03-23",{"date":77,"type":78},"2026-03-24","ACTUAL",{"date":80,"type":78},"2025-11-18",{"date":82,"type":59},"2031-04",{"name":5,"class":6},1]