NCT05462405Active, not recruiting
Evaluation of Sympathetic Activity Effects by the BackBeat Medical Cardiac Neuromodulation Therapy (CNT).
Microneurography MSNA Measurements for Evaluating the Effect of BackBeat Medical Cardiac Neuromodulation Therapy (CNT) on Sympathetic Activity: An Acute Study
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 14 Jul 2022
- Start date
- 10 Dec 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- BackBeat Medical Inc
- Diseases
- High blood pressure
- NCT number
- NCT05462405
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 10 Dec 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject has prior neurological events (stroke or TIA) within the past year or a neurological event (stroke) at any prior time that has resulted in residual neurologic deficit.
Other illness
- Subject has symptoms of heart failure, NYHA Class III or greater.
- Subject has decompensated heart failure
- Subject has a history of autonomic dysfunction.
Lab values
- Subject has an ejection fraction of 25% or less
Other
- Subject is dependent on 100% ventricular pacing.
- Subject's systolic blood pressure is less than 100 mm Hg on the day of recording.
- Subject has significant (\>3+) mitral regurgitation, aortic regurgitation, or aortic stenosis
- Subject has permanent atrial fibrillation.
- Subject has Atrial fibrillation on the day of the study.
- Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy, or interventricular septal thickness ≥15 mm.
- Subject is on dialysis
- Women who are pregnant or breast-feeding.
- Subject cannot or is unwilling to provide informed consent
Who the study is looking for
- Subject is already implanted with a Moderato IPG that can be used to deliver CNT pacing signals, whether CNT pacing was activated or not.
- Subject is willing and able to comply with the study and procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Semmelweis University - Heart and Vascular Center Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.