No phaseRecruiting
Novel Setup Algorithm for Cardiac Neuromodulation Therapy (CS-10)
Clinical Feasibility of a Novel Setup Algorithm for BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals
- Sponsor
- BackBeat Medical Inc (Industry)
- Enrolment
- 30 planned
- Conditions
- Hypertension; Bradycardia
- Interventions
- CNT testing
- Ages
- adults, older adults
- Registry
- NCT05719454
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- CNT efficacy: Changes in average 24 hour systolic ambulatory blood pressure
- CNT safety: Incidence of device- and treatment-related adverse and serious adverse
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered