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Completed

NCT Number: NCT04463121

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

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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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Essential Hypertension Heart Diseases Hypertension Hypertension, Systolic Isolated Systolic Hypertension Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Na Homolce Hospital

Prague, 15030, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moderato IPG's CNT pacing signals

Device

Assesment of cardiac function and sympatheric activity will be obtained simultaneously

CD Leycom Pressure/Volume Combination Catheters

Device

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

Primary outcomes

  1. Effects of the Moderato CNT pacing signals on cardiac function

    Time frame: approximately one hour

    Left ventricular pressure (mmHg) and Volume (ml) will be obtained by a multisensor catheter which provides real-time, beat-to-beat intra-ventricular measurement of cardiac function and performance. Data will be used to generate Pressure-Volume Loops, an aknowledged way to describe hemodynamic changes. CNT signals (alternating short and long atrioventicular sequences 40-150 ms) will be delivered at the same by right ventricular pacemaker leads temporarely connected to the Moderato device.

  2. Effects of CNT pacing signals on blood pressure

    Time frame: aproximately onr hour

    Blood pressure (mmHg) will be obtained in parallel with a Millar catheter from the femoral artery througout the study.

Sponsors and collaborators

Lead sponsor

BackBeat Medical Inc

Industry

Collaborators

  • CD Leycom

Registry information

Official study title

Pressure-Volume (PV) Measurements for Evaluating the Changes in the Ventricular Preload and Autonomic Nervous System Using BackBeat Medical Cardiac Neuromodulation Therapy (CNT) Signals in an Acute Study

Acronym: CS-06

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 9, 2020
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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