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

NCT05462405 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Experimental group

In the setting phase subjects will be in recumbent position. A microneurography needle (0.2mm diameter isolated Tungsten micro-electrode) will be placed under the skin. An identical (not isolated) reference needle tip will be inserted within 2 cm of the first electrode. These are connected to a recording system (ADInstruments PowerLab). Once sympathetic activity can be measured using the needles, a sympathetic specific test will be used to calibrate the measurement and recording system. In the testing phase sequential pacing and CNT delivery will be programmed for a few minutes, the whole procedure expected to last less than 2 hours.

Sponsors & Collaborators

  • BackBeat Medical Inc

    lead INDUSTRY

Principal Investigators

  • Bela Merkely, D, Ph.D. · Heart and vascular Centre, Semmelweiss University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-10
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • Hungary

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05462405 on ClinicalTrials.gov