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RECRUITING
NCT05719454
NA

Novel Setup Algorithm for Cardiac Neuromodulation Therapy

Sponsor: BackBeat Medical Inc

View on ClinicalTrials.gov

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

Interventions

DEVICE

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