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

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ClinicalTrials.gov Identifier: NCT04463121
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborator:
CD Leycom
Information provided by (Responsible Party):
BackBeat Medical Inc

Tracking Information
First Submitted Date  ICMJE June 30, 2020
First Posted Date  ICMJE July 9, 2020
Last Update Posted Date August 11, 2020
Actual Study Start Date  ICMJE August 7, 2020
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06)
Official Title  ICMJE 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
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Bradycardia
  • Hypertension, Systolic
Intervention  ICMJE
  • Device: Moderato IPG's CNT pacing signals
    Assesment of cardiac function and sympatheric activity will be obtained simultaneously
  • 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.
Study Arms  ICMJE Experimental: 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.

Interventions:
  • Device: Moderato IPG's CNT pacing signals
  • Device: CD Leycom Pressure/Volume Combination Catheters
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2020)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yuval Mika, PhD +18569123155 ymika@orchestrabiomed.com
Contact: Norbert Rosenthal +491792482543 nrosenthal@orchestrabiomed.com
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04463121
Other Study ID Numbers  ICMJE BBM MOD PV CS-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BackBeat Medical Inc
Study Sponsor  ICMJE BackBeat Medical Inc
Collaborators  ICMJE CD Leycom
Investigators  ICMJE
Principal Investigator: Petr Neuzil, MD, PhD Na Homolce Hospital
PRS Account BackBeat Medical Inc
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP