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RECRUITING Not applicable ClinicalTrials.gov

Novel Setup Algorithm for Cardiac Neuromodulation Therapy

Sponsor: BackBeat Medical Inc • ClinicalTrials.gov ID: NCT05719454

Registry updated: 2026-10-06
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Description

After meeting all inclusion/exclusion 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. The 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.

Interventions

  • CNT testing (Device)
    The effect of CNT on blood pressure will be obtained throughout the year long follow up period.

Eligibility criteria

Inclusion Criteria: * Subject is ≥ 18 years of age * Subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker. * 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. * Subject has an office systolic blood pressure (oSBP) ≥140 and \<180 mmHg * At 4 weeks from device implant, subject has an average 24-Hour ambulatory systolic blood pressure (aSBP) ≥130 mmHg and \<170 mmHg and an office blood pressure (oSBP) ≥140 and \<180 mmHg. * Subject is willing and able to comply with study visits and procedures * Subject is willing to adhere to the prescribed baseline antihypertension medical regimen for the duration of the study. Exclusion Criteria: * 1\. Subject has a known secondary cause of HTN (e.g. renal vascular disease, hyperthyroidism, hyperaldosterone and pheochromocytoma) * Subject has permanent atrial fibrillation * Subject has intermittent paroxysmal atrial fibrillation/flutter with significant burden (i.e., \>10% atrial fibrillation/flutter beats if available. * Subject has an ejection fraction \<50% * Subject has a drop of \> 15% (absolute) in ejection fraction from baseline to week 4 * Subject has symptoms of heart failure, NYHA Class II or greater * Subject has mitral regurgitation ≥2+, aortic stenosis with valve area \<1.0 cm2 , or is expected to need a valve repair or replacement. * Subject has a history of stroke or TIA within 12 months or any prior stroke with a residual neurological deficit (modified Rankin Score \>2+) * Subject experienced myocardial infarction (MI) within 3 months prior to enrolment * Subject had a cardiovascular interventional procedure or cardiovascular surgery within 6 months prior to enrolment * Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm * Subject is on dialysis * Subject has estimated glomerular filtration rate (GFR) \<30 ml/min/1.73m² * Subject has significant (\>50% occlusion of left or right carotid artery) carotid artery stenosis * Subject has a history of clinically significant untreated ventricular tachyarrhythmia or has experienced sudden cardiac arrest * Subject has an active device-based treatment for hypertension * Subject has an existing active cardiac device or neurostimulator (e.g., ICD, spinal cord stimulator) * Subject has Type I Diabetes * Subject is a member of a vulnerable population (e.g., prisoners, pregnant or lactating women, mentally disabled) * 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 * Subject cannot or is unwilling to provide informed consent

Conditions

Hypertension Bradycardia

Locations

  • Nemocnice Na Homolce (Na Homolce Hospital) — Prague, Czechia
  • Semmelweis University Heart and Vascular Center — Budapest, Hungary
  • Jagiellonian University Hospital — Krakow, Poland
  • Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Poland
  • Samodzielny Pub. Szpital Kliniczny nr 2 PUM — Szczecin, Poland
  • Publiczny Centralny Szpital — Warsaw, Poland
  • Silesian Center for Heart Diseases — Zabrze, Poland
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record