BradycardiaCS-06NCT04463121
Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06)
A study testing Moderato IPG's CNT pacing signals and CD Leycom Pressure/Volume Combination Catheters in people with Bradycardia and Hypertension, Systolic, run by BackBeat Medical Inc at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Hypertension, Systolic
- What is being tested?
- Moderato IPG's CNT pacing signals and CD Leycom Pressure/Volume Combination Catheters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Aug 2020to 16 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Bradycardia, Hypertension, Systolic
- Being tested
- Moderato IPG's CNT pacing signals, CD Leycom Pressure/Volume Combination Catheters
- Medical subject headings
- Bradycardia, Isolated Systolic Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderato IPG's CNT pacing signalsDevice
Assesment of cardiac function and sympatheric activity will be obtained simultaneously
CD Leycom Pressure/Volume Combination CathetersDevice
Simultaneous recording of the Pressure, Volume measurements and ECG signals will be done for constant monitoring of intra-ventricular pressure and volume.
| Study group | Role | What they receive |
|---|---|---|
| Acute CNT pacing signals testing | Experimental | 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. Receives: Device: Moderato IPG's CNT pacing signals; Device: CD Leycom Pressure/Volume Combination Catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately one hour
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.
Measured: aproximately onr hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start7 Aug 2020
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- BackBeat Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CD Leycom
- Responsible party
- Sponsor
- Investigators
- Petr Neuzil, MD, PhD, Principal investigator, Na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463121
- Sponsor's protocol ID
- BBM MOD PV CS-06
- Acronym
- CS-06
- Status last verified
- May 2026
- First submitted
- 30 Jun 2020
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29628351Neuzil 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.
PubMed 29275370de 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.
PubMed 23183349
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04463121
- Acronym / sponsor ID
- CS-06 / BBM MOD PV CS-06
- Conditions
- Bradycardia, Hypertension, Systolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- BackBeat Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- CD Leycom
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute CNT pacing signals testing | Experimental | Device: Moderato IPG's CNT pacing signals, Device: CD Leycom Pressure/Volume Combination CathetersAcute 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderato IPG's CNT pacing signalsAssesment of cardiac function and sympatheric activity will be obtained simultaneously | Device | Acute CNT pacing signals testing |
| CD Leycom Pressure/Volume Combination CathetersSimultaneous recording of the Pressure, Volume measurements and ECG signals will be done for constant monitoring of intra-ventricular pressure and volume. | Device | Acute CNT pacing signals testing |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 29628351Yang 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.
- Background: PubMed 29275370Neuzil 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.
- Background: PubMed 23183349de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Neuzil, MD, PhD principal investigator
Na Homolce Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderato IPG's CNT pacing signals and CD Leycom Pressure/Volume Combination Catheters in people with Bradycardia and Hypertension, Systolic, run by BackBeat Medical Inc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of the Moderato CNT pacing signals on cardiac function (time frame: approximately one hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04463121, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.