Novel Setup Algorithm for Cardiac Neuromodulation Therapy

Trial details

Who runs it

BackBeat Medical Inc

Trial code

NCT05719454

Record updated

6 October 2026

Original 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.Read full original descriptionShow less

Clinical Feasibility of a Novel Setup Algorithm for BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals

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.

Inclusion: 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: 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; 1. Subject has a known secondary cause of HTN (e.g. renal vascular disease, hyperthyroidism, hyperaldosterone and pheochromocytoma); Subject has symptoms of heart failure, NYHA Class II or greater; 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 has an ejection fraction <50%; Subject has a drop of > 15% (absolute) in ejection fraction from baseline to week 4; Subject has estimated glomerular filtration rate (GFR) <30 ml/min/1.73m²; 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 mitral regurgitation ≥2+, aortic stenosis with valve area <1.0 cm2 , or is expected to need a valve repair or replacement; Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm; Subject is on dialysis; Subject has significant (>50% occlusion of left or right carotid artery) carotid artery stenosis; 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.

ClinicalTrials.gov NCT05719454