[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618737":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":144,"collaborators":147,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":153,"sex":159,"minAge":160,"maxAge":20,"enrollmentInfo":161,"targetDuration":20,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":105,"whyStopped":20,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Columbia University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Barostim™ Therapy","EXPERIMENTAL","Participants will undergo implantation of the Barostim™ system, followed by device programming and titration according to standard clinical practice for up to three months after implantation.",[13],"Device: Baroreflex Activation Therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Baroreflex Activation Therapy","Barostim™ device (CVRx Inc.), a commercially available, FDA-approved device for autonomic modulation in HFrEF. The device system includes an implantable pulse generator, carotid sinus lead, and programmer system. No investigational modifications will be made. The device will be implanted per standard labeling and programming guidelines, and therapy titration will follow manufacturer recommendations.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Nir Uriel, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Morgan Smith, MD","CONTACT","914-629-3121","mds2225@cumc.columbia.edu",[32,52,70,88,103,116,128],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"University of California San Francisco Health","NOT_YET_RECRUITING","San Francisco","California","94143","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-122.41942,37.77493,{"lat":44,"lon":43},[47,51],{"name":48,"role":28,"phone":49,"phoneExt":20,"email":50},"Liviu Klein, MD","415-353-2873","liviu.klein@ucsf.edu",{"name":48,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":53,"status":34,"city":54,"state":55,"zip":56,"country":38,"countryCode":39,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"MedStar Health","Washington D.C.","District of Columbia","20010",{"type":41,"coordinates":58},[59,60],-77.03637,38.89511,{"lat":60,"lon":59},[63,67,68],{"name":64,"role":28,"phone":65,"phoneExt":20,"email":66},"Farooq H. Sheikh, MD","202-877-4698","farooq.h.sheikh@medstar.net",{"name":64,"role":24,"phone":20,"phoneExt":20,"email":20},{"name":69,"role":24,"phone":20,"phoneExt":20,"email":20},"Richa Gupta, MD",{"facility":71,"status":34,"city":72,"state":73,"zip":74,"country":38,"countryCode":39,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University of Chicago Medical Center","Chicago","Illinois","15212",{"type":41,"coordinates":76},[77,78],-87.65005,41.85003,{"lat":78,"lon":77},[81,85,86],{"name":82,"role":28,"phone":83,"phoneExt":20,"email":84},"Manreet Kanwar, MD","773-702-9461","manreetkanwar@uchicago.edu",{"name":82,"role":24,"phone":20,"phoneExt":20,"email":20},{"name":87,"role":24,"phone":20,"phoneExt":20,"email":20},"Mark Belkin, MD",{"facility":89,"status":34,"city":90,"state":90,"zip":91,"country":38,"countryCode":39,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Weill Cornell Medicine","New York","10021",{"type":41,"coordinates":93},[94,95],-74.00597,40.71427,{"lat":95,"lon":94},[98,102],{"name":99,"role":28,"phone":100,"phoneExt":20,"email":101},"Maria Karas, MD","646-962-5555","mgk2002@med.cornell.edu",{"name":99,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":104,"status":105,"city":90,"state":90,"zip":106,"country":38,"countryCode":39,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"Columbia University Irving Medical Center","RECRUITING","10032",{"type":41,"coordinates":108},[94,95],{"lat":95,"lon":94},[111,115],{"name":112,"role":28,"phone":113,"phoneExt":20,"email":114},"Gabriel T. Sayer, MD","212-342-3259","gts2102@cumc.columbia.edu",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":117,"status":34,"city":90,"state":90,"zip":118,"country":38,"countryCode":39,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"Montefiore Medical Center","10461",{"type":41,"coordinates":120},[94,95],{"lat":95,"lon":94},[123,127],{"name":124,"role":28,"phone":125,"phoneExt":20,"email":126},"Ulrich P. Jorde, MD","718-920-2626","ujorde@montefiore.org",{"name":124,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":129,"status":34,"city":130,"state":131,"zip":132,"country":38,"countryCode":39,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Medical University of South Carolina Health","Charleston","South Carolina","29425",{"type":41,"coordinates":134},[135,136],-79.93275,32.77632,{"lat":136,"lon":135},[139,143],{"name":140,"role":28,"phone":141,"phoneExt":20,"email":142},"Ryan J. Tedford, MD","843-792-1952","tedfordr@musc.edu",{"name":140,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":24,"investigatorFullName":145,"investigatorTitle":146,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Nir Uriel","Professor of Cardiology",[148],{"name":149,"class":150},"CVRx, Inc.","INDUSTRY","100618737","impact-of-barostimulation-on-hemodynamics-in-adults-with-heart-failure-100618737",false,"NCT07335510","Impact of Barostimulation on Hemodynamics in Adults With Heart Failure","Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device","BREATHE-HF","Inclusion Criteria:\n\n* Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12 months of screen)\n* Symptoms consistent with one of:\n\n  1. current New York Heart Association (NYHA) Class III or\n  2. current NYHA Class II and historical NYHA Class III\n* Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\\u003C 1600 pg\u002Fml (should be within 3 months of screen)\n* Management with maximally-tolerated GDMT medications and devices\n* Age \\>= 18 years\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening\n* Bilateral carotid bifurcations located above the level of the mandible\n* Carotid artery stenosis greater than 50% caused by atherosclerosis\n* Ulcerative plaques in the carotid artery\n* Baroreflex failure or autonomic neuropathy\n* Symptomatic un-controlled bradyarrhythmias\n* Severe chronic lung disease\n* Current treatment with inotropes\n* Pacemaker or ICD within 3 months of screening\n* Cardiac resynchronization therapy (CRT) devices within 6 months of screening or anticipated to be placed in the next 90 days following screening\n* Prior surgery, radiation, endovascular stent in the carotid sinus\n* History or consideration of solid organ transplantation\n* History or consideration of left ventricular assist device (LVAD)\n* Life expectancy \\\u003C1 year from time of screening\n* Non-cardiovascular conditions interfering with 6MWT distance assessment\n* Inability to fulfill protocol requirements\n* Known allergy to silicone or titanium","ALL","18 Years",{"count":162,"type":163},58,"ESTIMATED","INTERVENTIONAL",[166],"NA","This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed medical and device therapies. The study aims to assess how therapy using this device affects heart function, symptoms, and exercise capacity, with particular focus on how the device affects blood flow and heart pressures during exercise. Information from this study may help inform patient selection and device management in patients with heart failure.",[169],"HFrEF - Heart Failure With Reduced Ejection Fraction",[171,172,173,174,175,176,177],"Baroreflex activation therapy","Exercise hemodynamics","Barostim","Cardiopulmonary exercise testing","Neuromodulation","Functional capacity","Heart failure with reduced ejection fraction","2026-06-25",{"date":180,"type":181},"2026-06-29","ACTUAL",{"date":183,"type":181},"2026-03-30",{"date":185,"type":163},"2028-03",{"name":5,"class":6},7]