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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-07

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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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 from the other femoral artery with an additional sheath.

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.

Conditions

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Bradycardia Hypertension, Systolic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Acute CNT pacing signals testing

Acute study procedure will be carried out prior to a pacemaker implantation or replacement: pacemaker Right Atrial (RA) and Right Ventricular (RV) leads will be positioned according to standard procedure for pacemaker implant and connected to a Moderato® System IPG, via a single use, sterile Pacing System Analyzer (PSA) cable. The Moderato IPG will deliver CNT signals.

Furthermore, a standard conductance catheter in the left ventricle will measure cardiac volumes and pressure. Arterial blood pressure will be obtained as well.

A range of CNT signal parameters will be used to assess the effect on sympathetic activity at different positions of the RV pacing lead while ventricular pressure and volume and arteial pressure signals will be assesed for 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.

Group Type EXPERIMENTAL

Moderato IPG's CNT pacing signals

Intervention Type DEVICE

Assesment of cardiac function and sympatheric activity will be obtained simultaneously

CD Leycom Pressure/Volume Combination Catheters

Intervention Type DEVICE

Simultaneous recording of the Pressure, Volume measurements and ECG signals will be done for constant monitoring of intra-ventricular pressure and volume.

Interventions

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Moderato IPG's CNT pacing signals

Assesment of cardiac function and sympatheric activity will be obtained simultaneously

Intervention Type DEVICE

CD Leycom Pressure/Volume Combination Catheters

Simultaneous recording of the Pressure, Volume measurements and ECG signals will be done for constant monitoring of intra-ventricular pressure and volume.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Subject has symptoms of heart failure, NYHA Class II or greater
2. Subject has significant (\>2+) mitral regurgitation, aortic regurgitation or aortic stenosis.
3. Subject has permanent atrial fibrillation
4. Subject has atrial fibrillation on the day of the study.
5. Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
6. Subject is on dialysis
7. 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.
8. Subject has a history of autonomic dysfunction
9. Women who are pregnant or breast-feeding
10. Subject cannot or is unwilling to provide informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No