[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BackBeat Medical Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100639489","clinical-feasibility-of-cardiac-neuromodulation-therapy-for-heart-failure-with-preserved-ejection-fraction-100639489",false,"NCT07598760","Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction","Clinical Feasibility of Cardiac Neuromodulation Therapy (CNT) as Treatment for HFpEF","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Clinical indication for dual-chamber pacemaker implantation or replacement\n* Diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as left ventricular ejection fraction ≥50%\n* History of hypertension\n* NYHA functional class II or III\n* On stable guideline-directed medical therapy\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* NYHA class IV heart failure\n* Permanent or persistent atrial fibrillation\n* Recent acute decompensated heart failure\n* Significant valvular heart disease requiring intervention\n* Severe comorbid conditions that, in the investigator's judgment, would make study participation unsafe\n* Pregnant or breastfeeding individuals","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is an open-label pilot study to evaluate the feasibility of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who require dual-chamber pacemaker implantation or replacement. The study will assess blood pressure and heart function at rest and during exercise, with and without CNT, for up to 12 months. Participants will receive the Moderato Plus device and complete scheduled follow-up visits. After study completion, CNT therapy will be discontinued and participants will return to standard medical care.",[26,27,28],"Hypertension (HTN)","Heart Failure With Preserved Ejection Fraction (HFpEF","Hypertension, Systolic",[30,31,32],"CNT","HFpEF","Hypertension","NOT_YET_RECRUITING","2026-05-14",{"date":36,"type":37},"2026-05-20","ACTUAL",{"date":39,"type":20},"2026-05-30",{"date":41,"type":20},"2028-11-30",{"name":43,"class":44},"BackBeat Medical Inc","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100494536","novel-setup-algorithm-for-cardiac-neuromodulation-therapy-100494536","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",{"count":54,"type":20},30,[23],"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.",[32,58],"Bradycardia","RECRUITING","2026-03-06",{"date":62,"type":37},"2026-03-09",{"date":64,"type":37},"2023-06-21",{"date":66,"type":20},"2028-02-28",{"name":43,"class":44},7,""]