Novel Setup Algorithm for Cardiac Neuromodulation Therapy
Sponsor: BackBeat Medical Inc • ClinicalTrials.gov ID: NCT05719454
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Check Eligibility →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
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CNT testing
(Device)
The effect of CNT on blood pressure will be obtained throughout the year long follow up period.
Eligibility criteria
Conditions
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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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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