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

Primary Purpose

Bradycardia, Hypertension, Systolic

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Moderato IPG's CNT pacing signals
CD Leycom Pressure/Volume Combination Catheters
Sponsored by
BackBeat Medical Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bradycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Na Homolce HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute CNT pacing signals testing

Arm Description

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.

Outcomes

Primary Outcome Measures

Effects of the Moderato CNT pacing signals on cardiac function
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
Blood pressure (mmHg) will be obtained in parallel with a Millar catheter from the femoral artery througout the study.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2020
Last Updated
September 15, 2022
Sponsor
BackBeat Medical Inc
Collaborators
CD Leycom
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1. Study Identification

Unique Protocol Identification Number
NCT04463121
Brief Title
Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06)
Acronym
CS-06
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BackBeat Medical Inc
Collaborators
CD Leycom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Hypertension, Systolic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute CNT pacing signals testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Moderato IPG's CNT pacing signals
Intervention Description
Assesment of cardiac function and sympatheric activity will be obtained simultaneously
Intervention Type
Device
Intervention Name(s)
CD Leycom Pressure/Volume Combination Catheters
Intervention Description
Simultaneous recording of the Pressure, Volume measurements and ECG signals will be done for constant monitoring of intra-ventricular pressure and volume.
Primary Outcome Measure Information:
Title
Effects of the Moderato CNT pacing signals on cardiac function
Description
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.
Time Frame
approximately one hour
Title
Effects of CNT pacing signals on blood pressure
Description
Blood pressure (mmHg) will be obtained in parallel with a Millar catheter from the femoral artery througout the study.
Time Frame
aproximately onr hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Mika, PhD
Phone
+18569123155
Email
ymika@orchestrabiomed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Norbert Rosenthal
Phone
+491792482543
Email
nrosenthal@orchestrabiomed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petr Neuzil, MD, PhD
Organizational Affiliation
Na Homolce Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Na Homolce Hospital
City
Praha
ZIP/Postal Code
15030
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Neuzil, MD, PhD
Phone
+420 257272211
Email
Peter.Neuzil@homolka.cz
First Name & Middle Initial & Last Name & Degree
Libor Dujka, MD
Phone
+420731486352
Email
libor.dujka@homolka.cz
First Name & Middle Initial & Last Name & Degree
Petr Neuzil, MD, PhD
First Name & Middle Initial & Last Name & Degree
Filip Malek, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jan Petru, MD
First Name & Middle Initial & Last Name & Degree
Milan Chovanec, MD
First Name & Middle Initial & Last Name & Degree
Libor Dujka, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
29628351
Citation
Yang B, Wang Y, Zhang F, Ju W, Chen H, Mika Y, Aviv R, Evans SJ, Burkhoff D, Wang J, Chen M. Rationale and evidence for the development of a durable device-based cardiac neuromodulation therapy for hypertension. J Am Soc Hypertens. 2018 May;12(5):381-391. doi: 10.1016/j.jash.2018.03.004. Epub 2018 Mar 21.
Results Reference
background
PubMed Identifier
29275370
Citation
Neuzil P, Merkely B, Erglis A, Marinskis G, de Groot JR, Schmidinger H, Rodriguez Venegas M, Voskuil M, Sturmberger T, Petru J, Jongejan N, Aichinger J, Kamzola G, Aidietis A, Geller L, Mraz T, Osztheimer I, Mika Y, Evans S, Burkhoff D, Kuck KH; BackBeat Study Investigators. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017 Dec 23;6(12):e006974. doi: 10.1161/JAHA.117.006974.
Results Reference
background
PubMed Identifier
23183349
Citation
de Roest GJ, Allaart CP, Kleijn SA, Delnoy PP, Wu L, Hendriks ML, Bronzwaer JG, van Rossum AC, de Cock CC. Prediction of long-term outcome of cardiac resynchronization therapy by acute pressure-volume loop measurements. Eur J Heart Fail. 2013 Mar;15(3):299-307. doi: 10.1093/eurjhf/hfs190. Epub 2012 Nov 25.
Results Reference
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Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06)

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