Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06)

  • STATUS
    Recruiting
  • End date
    Mar 1, 2022
  • participants needed
    15
  • sponsor
    BackBeat Medical Inc
Updated on 7 May 2021
Investigator
Yuval Mika, PhD
Primary Contact
Na Homolce Hospital (1.2 mi away) Contact
electrocardiogram
hypertension

Summary

This investigation will evaluate the effect of RV pacing lead position on cardiac function and the modulation of the autonomic nervous system with Cardiac Neuromodulation Therapy (CNT) pacing signals. The study will be performed acutely prior to a pacemaker implant.

Description

Subjects indicated for a dual chamber pacemaker implant or replacement who are not 100% dependent on right ventricular pacing may be eligible to participate in the study.

This investigation will evaluate the effect of RV pacing lead position on cardiac function and the modulation of the autonomic nervous system using Cardiac Neuromodulation Therapy (CNT) pacing signals at different positions of the RV pacing lead.

A standard conductance catheter will be introduced through the femoral artery and advanced into the left ventricle to measure cardiac volumes and pressure.

Arterial blood pressure will be measured either from the femoral artery sheath through which the conductance catheter is introduced, or from a radial arterial line.

The Moderato IPG will be used to generate Cardiac Neuromodulation Therapy (CNT) signals and deliver them to the patient through the cable and leads. A range of CNT signal parameters will be used to assess the effect on sympathetic activity at different positions of the RV pacing lead. Ventricular pressure and volume readings from the conductance catheter and arterial pressure readings will be recorded and analyzed to assess the effect of CNT signals on cardiac function, sympathetic activity and blood pressure.

The effects of CNT signal over a range of parameter settings will be studied for the different RV lead positions.

Details
Condition Arrhythmia, Bradycardia, Systolic Hypertension, Dysrhythmia, Hypertension, Systolic, Hypertension, Systolic, Hypertension, Systolic, Hypertension, Systolic
Treatment Moderato IPG's CNT pacing signals, CD Leycom Pressure/Volume Combination Catheters
Clinical Study IdentifierNCT04463121
SponsorBackBeat Medical Inc
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is 18 years of age
Subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker
Subject has known Hypertension
Subject is willing and able to comply with the study and procedures

Exclusion Criteria

Subject has symptoms of heart failure, NYHA Class II or greater
Subject has significant (>2+) 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 a history of prior neurological events (stroke or TIA) within the past year or a neurological event (stroke or TIA) 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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