[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639489":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":20,"id":46,"slug":20,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":20,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":20,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":69,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"BackBeat Medical Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cardiac Neuromodulation Therapy","EXPERIMENTAL","Participants receive the Moderato Plus device with Cardiac Neuromodulation Therapy",[13],"Device: Moderato Plus device with Cardiac Neuromodulation Therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Moderato Plus device with Cardiac Neuromodulation Therapy","Moderato Plus System with CNT",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Ziv Belsky","CONTACT","201-691-4240","zbelsky@orchestrabiomed.com",[28,39],{"facility":29,"status":20,"city":30,"state":20,"zip":20,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":20},"Georgian Medical Research Clinic Healthycore","Tbilisi","Georgia","GE",{"type":34,"coordinates":35},"Point",[36,37],44.83412,41.69143,{"lat":37,"lon":36},{"facility":40,"status":20,"city":30,"state":20,"zip":20,"country":31,"countryCode":32,"cosmosGeoPoint":41,"geoPoint":43,"contacts":20},"Tbilisi Heart and Vascular Clinic",{"type":34,"coordinates":42},[36,37],{"lat":37,"lon":36},{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":55,"type":56},20,"ESTIMATED","INTERVENTIONAL",[59],"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.",[62,63,64],"Hypertension (HTN)","Heart Failure With Preserved Ejection Fraction (HFpEF","Hypertension, Systolic",[66,67,68],"CNT","HFpEF","Hypertension","NOT_YET_RECRUITING","2026-05-14",{"date":72,"type":73},"2026-05-20","ACTUAL",{"date":75,"type":56},"2026-05-30",{"date":77,"type":56},"2028-11-30",{"name":5,"class":6},2]