[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494536":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":140,"collaborators":28,"id":142,"slug":28,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":143,"sex":149,"minAge":150,"maxAge":28,"enrollmentInfo":151,"targetDuration":28,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":28,"overallStatus":58,"whyStopped":28,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"BackBeat Medical Inc","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"CNT Setup Algorithm Version 1","EXPERIMENTAL","When performing the Setup Algorithm Version 1, each subject's blood pressure is measured with a standard cuff system while the BackBeat-CNT is activated, and system parameters are varied successively according to a specified sequence or based on the blood pressure measurements obtained during previous activations of BackBeat CNT, until the Setup Algorithm is complete. The parameter values as determined by the Setup Algorithm will constitute the programming of the Moderato IPG for the 24 hour activation following setup.",[13],"Device: CNT testing",{"label":15,"type":10,"description":11,"interventionNames":16},"CNT Setup Algorithm Version 2",[13],{"label":18,"type":19,"description":20,"interventionNames":21},"CNT therapy optimization without use of the Setup Algorithm","OTHER","For this optimization procedure, each subject's blood pressure is measured with a continuous blood pressure measurement system while the BackBeat-CNT is activated, and system parameters are varied according to a specified sequence until the desired blood pressure reduction is achieved. The parameter values that provide the desired blood pressure reduction will be recorded, for possible use by the investigator following trial completion",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","CNT testing","The effect of CNT on blood pressure will be obtained throughout the year long follow up period.",[9,15,18],null,[30],{"name":31,"affiliation":32,"role":33},"Béla MERKELY, Prof. MD","Semmelweis University Heart and Vascular Center","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Linda Korthout","CONTACT","+41783482383","lkorthout@orchestrabiomed.com",[41,57,78,92,104,116,128],{"facility":42,"status":43,"city":44,"state":28,"zip":45,"country":46,"countryCode":28,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Nemocnice Na Homolce (Na Homolce Hospital)","NOT_YET_RECRUITING","Prague","15030","Czechia",{"type":48,"coordinates":49},"Point",[50,51],14.42076,50.08804,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":28,"phoneExt":28,"email":56},"Petr Neužil,, Prof.Dr.","pneuzil@seznam.cz",{"facility":32,"status":58,"city":59,"state":28,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"RECRUITING","Budapest","1122","Hungary","HU",{"type":48,"coordinates":64},[65,66],19.04045,47.49835,{"lat":66,"lon":65},[69,73,77],{"name":70,"role":37,"phone":71,"phoneExt":28,"email":72},"Béla Merkely, Prof.","+36 1 458 6842","merkely.bela@kardio.sote.hu",{"name":74,"role":37,"phone":75,"phoneExt":28,"email":76},"Istvan Osztheimer, MD","+36 20 6632487","osztheimer.istvan@kardio.sote.hu",{"name":70,"role":33,"phone":28,"phoneExt":28,"email":28},{"facility":79,"status":43,"city":80,"state":28,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Jagiellonian University Hospital","Krakow","30-688","Poland","PL",{"type":48,"coordinates":85},[86,87],19.93658,50.06143,{"lat":87,"lon":86},[90],{"name":91,"role":37,"phone":28,"phoneExt":28,"email":28},"Marek Jastrzębski, Prof.",{"facility":93,"status":43,"city":94,"state":28,"zip":95,"country":82,"countryCode":83,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Uniwersytecki Szpital Kliniczny w Poznaniu","Poznan","61-848",{"type":48,"coordinates":97},[98,99],16.92993,52.40692,{"lat":99,"lon":98},[102],{"name":103,"role":37,"phone":28,"phoneExt":28,"email":28},"Przemysław Mitkowski, Dr.",{"facility":105,"status":43,"city":106,"state":28,"zip":107,"country":82,"countryCode":83,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Samodzielny Pub. Szpital Kliniczny nr 2 PUM","Szczecin","72 70-111",{"type":48,"coordinates":109},[110,111],14.55302,53.42894,{"lat":111,"lon":110},[114],{"name":115,"role":37,"phone":28,"phoneExt":28,"email":28},"Jaroslaw Kazmierczak, Prof. Dr.",{"facility":117,"status":43,"city":118,"state":28,"zip":119,"country":82,"countryCode":83,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Publiczny Centralny Szpital","Warsaw","02-097",{"type":48,"coordinates":121},[122,123],21.01178,52.22977,{"lat":123,"lon":122},[126],{"name":127,"role":37,"phone":28,"phoneExt":28,"email":28},"Marcin Grabowski, Prof. Dr.",{"facility":129,"status":43,"city":130,"state":28,"zip":131,"country":82,"countryCode":83,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Silesian Center for Heart Diseases","Zabrze","41-800",{"type":48,"coordinates":133},[134,135],18.78576,50.32492,{"lat":135,"lon":134},[138],{"name":139,"role":37,"phone":28,"phoneExt":28,"email":28},"Adam Sokal, Dr.",{"type":141,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100494536",false,"NCT05719454","Novel Setup Algorithm for Cardiac Neuromodulation Therapy","Clinical Feasibility of a Novel Setup Algorithm for BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals","CS-10","Inclusion Criteria:\n\n* Subject is ≥ 18 years of age\n* Subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker.\n* Subject has stable (for prior 1 month) hypertension treatment with 1, 2 or 3 antihypertensive drugs, which is planned to be maintained without changes for a period of at least 2 months post implant.\n* Subject has an office systolic blood pressure (oSBP) ≥140 and \\\u003C180 mmHg\n* At 4 weeks from device implant, subject has an average 24-Hour ambulatory systolic blood pressure (aSBP) ≥130 mmHg and \\\u003C170 mmHg and an office blood pressure (oSBP) ≥140 and \\\u003C180 mmHg.\n* Subject is willing and able to comply with study visits and procedures\n* Subject is willing to adhere to the prescribed baseline antihypertension medical regimen for the duration of the study.\n\nExclusion Criteria:\n\n* 1\\. Subject has a known secondary cause of HTN (e.g. renal vascular disease, hyperthyroidism, hyperaldosterone and pheochromocytoma)\n* Subject has permanent atrial fibrillation\n* Subject has intermittent paroxysmal atrial fibrillation\u002Fflutter with significant burden (i.e., \\>10% atrial fibrillation\u002Fflutter beats if available.\n* Subject has an ejection fraction \\\u003C50%\n* Subject has a drop of \\> 15% (absolute) in ejection fraction from baseline to week 4\n* Subject has symptoms of heart failure, NYHA Class II or greater\n* Subject has mitral regurgitation ≥2+, aortic stenosis with valve area \\\u003C1.0 cm2 , or is expected to need a valve repair or replacement.\n* Subject has a history of stroke or TIA within 12 months or any prior stroke with a residual neurological deficit (modified Rankin Score \\>2+)\n* Subject experienced myocardial infarction (MI) within 3 months prior to enrolment\n* Subject had a cardiovascular interventional procedure or cardiovascular surgery within 6 months prior to enrolment\n* Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm\n* Subject is on dialysis\n* Subject has estimated glomerular filtration rate (GFR) \\\u003C30 ml\u002Fmin\u002F1.73m²\n* Subject has significant (\\>50% occlusion of left or right carotid artery) carotid artery stenosis\n* Subject has a history of clinically significant untreated ventricular tachyarrhythmia or has experienced sudden cardiac arrest\n* Subject has an active device-based treatment for hypertension\n* Subject has an existing active cardiac device or neurostimulator (e.g., ICD, spinal cord stimulator)\n* Subject has Type I Diabetes\n* Subject is a member of a vulnerable population (e.g., prisoners, pregnant or lactating women, mentally disabled)\n* Subject has the possibility of becoming pregnant during the conduct of the study and is not willing to use a means of contraception during the study\n* Subject cannot or is unwilling to provide informed consent","ALL","18 Years",{"count":152,"type":153},30,"ESTIMATED","INTERVENTIONAL",[156],"NA","After meeting all inclusion\u002Fexclusion criteria, subjects on standard pacing with the Moderato® or Moderato Plus Implantable Pulse Generator (IPG) will be subjected to two set-up sessions for the CNT algorithm: at week 4 and at week 6 post implant. At the end of these visits, subjects will undergo a 24 ambulatory blood pressure recording after which CNT will be automatically turned OFF and standard pacing will resume.\n\nThe ambulatory data will provide the basis for a lasting CNT programming by week 8. Follow up visits will be scheduled after 3, 6, and 12 months.",[159,160],"Hypertension","Bradycardia","2026-03-06",{"date":163,"type":164},"2026-03-09","ACTUAL",{"date":166,"type":164},"2023-06-21",{"date":168,"type":153},"2028-02-28",{"name":5,"class":6},7]