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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

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.

Condition or disease Intervention/treatment Phase
Bradycardia Hypertension, Systolic Device: Moderato IPG's CNT pacing signals Device: CD Leycom Pressure/Volume Combination Catheters Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04463121


Contacts
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Contact: Yuval Mika, PhD +18569123155 ymika@orchestrabiomed.com
Contact: Norbert Rosenthal +491792482543 nrosenthal@orchestrabiomed.com

Locations
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Czechia
Na Homolce Hospital Recruiting
Praha, Czechia, 15030
Contact: Petr Neuzil, MD, PhD    +420 257272211    Peter.Neuzil@homolka.cz   
Contact: Libor Dujka, MD    +420731486352    libor.dujka@homolka.cz   
Principal Investigator: Petr Neuzil, MD, PhD         
Sub-Investigator: Filip Malek, MD, PhD         
Sub-Investigator: Jan Petru, MD         
Sub-Investigator: Milan Chovanec, MD         
Sub-Investigator: Libor Dujka, MD         
Sponsors and Collaborators
BackBeat Medical Inc
CD Leycom
Investigators
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Principal Investigator: Petr Neuzil, MD, PhD Na Homolce Hospital
Publications:
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Responsible Party: BackBeat Medical Inc
ClinicalTrials.gov Identifier: NCT04463121    
Other Study ID Numbers: BBM MOD PV CS-06
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bradycardia
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes