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

January 9, 2023 updated by: BackBeat Medical Inc

Microneurography MSNA Measurements for Evaluating the Effect of BackBeat Medical Cardiac Neuromodulation Therapy (CNT) on Sympathetic Activity: An Acute Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a multi-center , open-label, non-randomized acute pilot study. The Moderato System is approved for marketing in Europe (has a CE mark) for standard pacing and the treatment of high blood pressure in patients requiring standard cardiac pacing. The therapy delivered by the Moderato system is referred to as CNT (Cardiac Neuromodulation Therapy).

Measurement and recording of Muscle Sympathetic Neural Activity (MSNA) using microneurography, has been used extensively [see reference 4,5]. A small, thin metal needle is inserted through the skin near the knee in proximity to a major nerve that is close to the skin (a few millimeters depth). The electrical activity of the nerve measured by the needle is a direct indication of peripheral sympathetic activity.

This measurement technique will be applied to subjects who are already implanted with a Moderato IPG that can deliver the BackBeat CNT pacing signals, whether CNT pacing was activated or not.

In recumbent position (lying in a bed), insertion of a microneurography needle (FHC 35mm long, 0.2mm diameter Tungsten microelectrodes model UNP35F2U) to the correct recording position is attempted for no more than 1 hour. This has been successful in approximately 75% of patients in previous MSNA studies. An identical reference needle is inserted within 2 cm of the first electrode. The needles are connected to a recording system (ADInstruments PowerLab). Once sympathetic activity can be measured using the needles, a cold pressor test is performed. In this test, the subject's hand is placed in cold water for up to 2 minutes. This test is known to affect sympathetic activity and is used to calibrate the measurement and recording system.

The Moderato Programmer is then used to program the implanted Moderato IPG to deliver different sets of CNT pacing signals parameters, each for several minutes with a several minutes interval between delivery periods. This delivery pattern is used in order to measure the effect of CNT pacing signals delivery on sympathetic activity level both during and after CNT pacing signals delivery. Subject blood pressure, respiration and ECG data is also collected and recorded, both for safety reasons and to evaluate the effect of CNT on secondary indicators of sympathetic activity.

After the different CNT pacing signal sets are delivered, the microneurography needles will be removed, the patient disconnected from all other measurement devices, and the procedure concluded.

Patients will be considered as having completed the study at the conclusion of the acute procedure unless a safety event is observed during the acute procedure in which case the patients will be followed until the event has been resolved.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Semmelweis University Heart and Vascular Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subject is dependent on 100% ventricular pacing.
  • Subject has symptoms of heart failure, NYHA Class III or greater.
  • Subject has an ejection fraction of 25% or less
  • Subject's systolic blood pressure is less than 100 mm Hg on the day of recording.
  • Subject has decompensated heart failure
  • 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
  • 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.
  • Subject has a history of autonomic dysfunction.
  • Women who are pregnant or breast-feeding.
  • Subject cannot or is unwilling to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
All subjects enrolled will be in the same experimental group.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sympathetic activity will be calculated as burst frequency (bursts/min) and as burst incidence (bursts/100 heartbeats). A change in the nerve activity occurring between pacing and CNT is expected.
Time Frame: through study completion (18 months)
Nerve firing is organised in burst activity which can be detected by the data acquisition system
through study completion (18 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A change in Systolic Blood Pressure
Time Frame: through study completion (18 months)
CNT main action is a reduction of the Systolic Blood Pressure
through study completion (18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BackBeat Medical Inc

Investigators

  • Principal Investigator: Bela Merkely, D, Ph.D., Heart and vascular Centre, Semmelweiss University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 14, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-09 BBM MSNA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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