Clinical Trial

Evaluation of Sympathetic Activity Effects by the BackBeat Medical Cardiac Neuromodulation Therapy (CNT).

Active, Not Recruiting
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Summary
Measurement and recording of Muscle Sympathetic Neural Activity (MSNA) using microneurography, will be applied to subjects who have been already implanted with a Moderato IPG delivering the BackBeat CNT and/or pacing signals. Several tests will be performed by experienced professionals to ensure the acquired sympathetic nerve signals arise from the targeted nerve source. The Moderato Programmer will be then used to program different sets of CNT for several minutes with a several minutes interval between delivery periods. This delivery pattern is used will allow to acquire sympathetic nerve signals with and without CNT. Subject blood pressure, respiration and ECG data will be collected and recorded, both for safety and for evaluation of CNT dependent secondary indicators of sympathetic activity.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-07-14; most recent amendment 2026-05-04.
Status change: Recruiting → Active, Not Recruiting 2026-05-04
Status change: Not Yet Recruiting → Recruiting 2022-12-12
Trial Details
NCT Number NCT05462405
Lead Sponsor BackBeat Medical Inc
Conditions Hypertension
Enrollment 15 participants
Start Date 2022-12-10
Primary Completion 2026-12 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-05