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Novel Setup Algorithm for Cardiac Neuromodulation Therapy
Sponsor: BackBeat Medical Inc
Summary
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.
Official title: Clinical Feasibility of a Novel Setup Algorithm for BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-06-21
Completion Date
2028-02-28
Last Updated
2026-03-09
Healthy Volunteers
No
Conditions
Interventions
CNT testing
The effect of CNT on blood pressure will be obtained throughout the year long follow up period.
Locations (7)
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