Novel Setup Algorithm for Cardiac Neuromodulation Therapy

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.

NCT Number	NCT05719454
Lead Sponsor	BackBeat Medical Inc
Conditions	Hypertension, Bradycardia
Enrollment	30 participants
Start Date	2023-06-21
Primary Completion	2027-01-31 (estimated)
Study Completion	2028-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-03-09