BradycardiaCS-07NCT05345925
PV Loops With CNT in Multiple Pacing Sites
A study testing Moderato in people with Bradycardia and A-V Block, run by BackBeat Medical Inc at 1 site in Poland.
Trial summary
In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, A-V Block
- What is being tested?
- Moderato
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 sitePoland
- Study dates
- 19 May 2023to 14 Nov 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 is indicated for an implant or a replacement with a planned upgrade of a device capable of pacing (pacemaker, ICD, CRT-P, CRT-D).
- Subject is willing and able to comply with the study procedures.
Who cannot join
- Subject is dependent on 100% ventricular pacing.
- Subject has symptoms of heart failure, NYHA Class III or greater
- Subject has an ejection fraction of 25% or less
- Subject's systolic blood pressure is less than 100 mmHg on the day of implant
- Subject has decompensated heart failure
- Subject has significant (>2+) valvular regurgitation or any valvular stenosis.
Show all 15Show fewer
- 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) at any prior time that has resulted in residual neurologic deficit.
- Subject has a history of autonomic dysfunction
- Patient cannot receive heparin for any reason (such as a history of Heparin induced thrombocytopenia (HIT))
- 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 Cardiac Parameters Using BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals in Different Physiological Pacing Sites: An Acute Study
In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV. CNT effects on BP will be evaluated with a PV conductance catheter in the LV, and with optional BP catheters in the aorta and/or RV. CNT will be delivered by externally by the BackBeat Moderato System IPG.
Abbreviations: CNT, Cardiac Neuromodulation Therapy; IPG, Implanted Pulse Generator; ICD, Implanted Cardiac Defribillator; CRT-P or D, Cardiac Resynchronisation Therapy-Pacemaker or Defibrillator; RV, Right Ventricle; LV, Left Ventricle; BP, Blood Pressure
Read the detailed description
This will be a multi-center, pilot, open-label, non-randomized acute study. The Moderato System is approved for marketing in Europe (has a CE mark) for standard pacing and the treatment of high blood pressure in patients requiring standard cardiac pacing. The therapy delivered by the Moderato® System is referred to as CNT (Cardiac Neuromodulation Therapy).
This investigation will evaluate the effect of different pacing lead positions on cardiac function and the modulation of the autonomic nervous system using Cardiac Neuromodulation Therapy (CNT) pacing signals. The Study includes both patient who have hypertension and patients that do not have hypertension. Moderato®system is currently not indicated for patients that do not have hypertension.
Subjects indicated for an implant or replacement of a device capable of pacing (pacemaker, ICD, CRT-P, CRT-D) who meet the study inclusion and exclusion criteria may participate in the study and will undergo the following procedure during their device implantation or replacement:
A Right Atrial (RA) lead will be positioned according to standard procedure of the initially planned device implant, or kept in place (in device replacement), or only temporarily introduced and used for the trial procedure. Existing ventricular leads (if any) can be used for the trial procedure, too. The ventricular lead will be temporarily positioned in the different pacing sites according to the following order: RV septal, LBBA, LBB. Pacing and CNT will be performed in each of these sites unless the site is unreachable or pacing is not possible. When trial procedures are finished, the ventricular lead will be positioned according to best practices of the implant or replacement procedure the patient is undergoing. Any lead used temporarily would be removed.
The leads will be connected to a BackBeat Moderato® System IPG, externally to the patient, using a single use, sterile Pacing System Analyzer (PSA) cable provided by the hospital. The Moderato®IPG - which is approved for chronic CNT delivery in hypertensive patients - will function in this trial as a temporary external CNT signal generator for acute application of the therapy; it will not be in direct contact with the subject.
A standard conductance catheter (CD Leycom, The Netherlands) 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 by introducing a pressure sensor (e.g., Millar catheter) either from another femoral artery sheath or from a radial arterial line.
Right ventricular blood pressure measurements will be taken by introducing a pressure sensor (e.g., Millar catheter) to the right ventricle through an axillary or subclavian sheath.
The Moderato®IPG will be used to generate standard pacing and 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 the different lead positions. Ventricular pressure and volume readings from the conductance catheter, arterial pressure readings and right ventricle 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 in the different lead positions.
Simultaneous recording of the ventricular and arterial pressures, ventricular volume measurements and ECG signals will be performed in every pacing site during both pacing and CNT using the LEYCOM® Inca (IntraCardiac Analyzer) system, an integrated, stand-alone system for constant monitoring of intra-ventricular pressure and volume (CE marked).
In this study, none of the Moderato® system components will be in contact with the patient. The Moderato® IPG will be used solely as an external CNT signal generator and deliver signals to the patient through the PSA cable and the pacemaker leads.
When CNT signal activation is complete, data recording will be stopped, the conductance catheter will be removed, the cable connecting the IPG to the leads disconnected, and device implantation (or replacement) will proceed normally. Any pacing lead used temporarily would be removed if not required for ongoing patient treatment.
Patients will be considered as having completed the study at the conclusion of the acute procedure unless a safety event is observed during the acute procedure in which case the patients will be followed until the event has been resolved.
- Conditions
- Bradycardia, A-V Block
- Being tested
- Moderato
- Medical subject headings
- Bradycardia, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModeratoDevice
Several algorithms comprising CNT will be delivered by the Moderato Implantable Pulse Generator. Each application will last approximately 3 min with 2 minutes baseline (regular pacing) between them. Hence, each subject will serve as its own control (during pacing) and test (during CNT application). Furthermore, the average control value for the whole group will be compared with the average test values of CNT algorithms at the different ventricular lead locations for efficacy assessments. Stratification of subjects by initial hemodynamic parameters (such as Ejection Fraction, for example) would be possible depending on the total number of subjects in each group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Eligible subjects instrumented for CNT testing Receives: Device: Moderato |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average changes in Systolic Blood Pressure Change
When compared to standard pacing, CNT elicits a reduction in Systolic Blood Pressure (mmHg)
Measured: through study completion (18 months)
Secondary outcomes (5)
Average Cardiac Volumes (End Diastolic and End Systolic volumes, stroke volumes)
When compared to standard pacing, CNT varies cardiac volumes (ml)
Measured: through study completion (18 months)
Average Ejection Fraction (the percent of blood volume ejected per beat)
When compared to standard pacing, CNT varies Ejection Fraction (EF, %)
Measured: through study completion (18 months)
Average Cardiac Pressures (End Systolic and Diastolic Pressures)
When compared to standard pacing, CNT varies cardiac pressures (mmHg)
Measured: through study completion (18 months)
Average cardiac contractility
When compared to standard pacing, CNT varies cardiac contractility (mmHg/sec)
Measured: through study completion (18 months)
Average Systemic Vascular Resistance
When compared to standard pacing, CNT Systemic Resistance (ml/mmHg/sec)
Measured: through study completion (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start19 May 2023
- Primary completion11 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- BackBeat Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CD Leycom
- Responsible party
- Sponsor
- Investigators
- Marek Jastrzębski,, MD, PhD, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345925
- Sponsor's protocol ID
- BBM PV-PHYS CS-07
- Acronym
- CS-07
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klotz S, Dickstein ML, Burkhoff D. A computational method of prediction of the end-diastolic pressure-volume relationship by single beat. Nat Protoc. 2007;2(9):2152-8. doi: 10.1038/nprot.2007.270.
PubMed 17853871Neuzil 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 29275370Yang 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 29628351Kalarus Z, Merkely B, Neuzil P, Grabowski M, Mitkowski P, Marinskis G, Erglis A, Kazmierczak J, Sturmberger T, Sokal A, Pluta S, Geller L, Osztheimer I, Malek F, Kolodzinska A, Mika Y, Evans SJ, Hastings HM, Burkhoff D, Kuck KH. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study. J Am Heart Assoc. 2021 Aug 17;10(16):e020492. doi: 10.1161/JAHA.120.020492. Epub 2021 Aug 13.
PubMed 34387126
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure-Volume (PV) Measurements for Evaluating Cardiac Parameters Using BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals in Different Physiological Pacing Sites: An Acute Study
- ClinicalTrials.gov ID
- NCT05345925
- Acronym / sponsor ID
- CS-07 / BBM PV-PHYS CS-07
- Conditions
- Bradycardia, A-V Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- BackBeat Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- CD Leycom
- Study start
- 19 May 2023 (actual)
- Primary completion
- 11 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 26 Apr 2022 (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.
In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV. CNT effects on BP will be evaluated with a PV conductance catheter in the LV, and with optional BP catheters in the aorta and/or RV. CNT will be delivered by externally by the BackBeat Moderato System IPG.
Abbreviations: CNT, Cardiac Neuromodulation Therapy; IPG, Implanted Pulse Generator; ICD, Implanted Cardiac Defribillator; CRT-P or D, Cardiac Resynchronisation Therapy-Pacemaker or Defibrillator; RV, Right Ventricle; LV, Left Ventricle; BP, Blood Pressure
Detailed description
This will be a multi-center, pilot, open-label, non-randomized acute study. The Moderato System is approved for marketing in Europe (has a CE mark) for standard pacing and the treatment of high blood pressure in patients requiring standard cardiac pacing. The therapy delivered by the Moderato® System is referred to as CNT (Cardiac Neuromodulation Therapy).
This investigation will evaluate the effect of different pacing lead positions on cardiac function and the modulation of the autonomic nervous system using Cardiac Neuromodulation Therapy (CNT) pacing signals. The Study includes both patient who have hypertension and patients that do not have hypertension. Moderato®system is currently not indicated for patients that do not have hypertension.
Subjects indicated for an implant or replacement of a device capable of pacing (pacemaker, ICD, CRT-P, CRT-D) who meet the study inclusion and exclusion criteria may participate in the study and will undergo the following procedure during their device implantation or replacement:
A Right Atrial (RA) lead will be positioned according to standard procedure of the initially planned device implant, or kept in place (in device replacement), or only temporarily introduced and used for the trial procedure. Existing ventricular leads (if any) can be used for the trial procedure, too. The ventricular lead will be temporarily positioned in the different pacing sites according to the following order: RV septal, LBBA, LBB. Pacing and CNT will be performed in each of these sites unless the site is unreachable or pacing is not possible. When trial procedures are finished, the ventricular lead will be positioned according to best practices of the implant or replacement procedure the patient is undergoing. Any lead used temporarily would be removed.
The leads will be connected to a BackBeat Moderato® System IPG, externally to the patient, using a single use, sterile Pacing System Analyzer (PSA) cable provided by the hospital. The Moderato®IPG - which is approved for chronic CNT delivery in hypertensive patients - will function in this trial as a temporary external CNT signal generator for acute application of the therapy; it will not be in direct contact with the subject.
A standard conductance catheter (CD Leycom, The Netherlands) 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 by introducing a pressure sensor (e.g., Millar catheter) either from another femoral artery sheath or from a radial arterial line.
Right ventricular blood pressure measurements will be taken by introducing a pressure sensor (e.g., Millar catheter) to the right ventricle through an axillary or subclavian sheath.
The Moderato®IPG will be used to generate standard pacing and 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 the different lead positions. Ventricular pressure and volume readings from the conductance catheter, arterial pressure readings and right ventricle 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 in the different lead positions.
Simultaneous recording of the ventricular and arterial pressures, ventricular volume measurements and ECG signals will be performed in every pacing site during both pacing and CNT using the LEYCOM® Inca (IntraCardiac Analyzer) system, an integrated, stand-alone system for constant monitoring of intra-ventricular pressure and volume (CE marked).
In this study, none of the Moderato® system components will be in contact with the patient. The Moderato® IPG will be used solely as an external CNT signal generator and deliver signals to the patient through the PSA cable and the pacemaker leads.
When CNT signal activation is complete, data recording will be stopped, the conductance catheter will be removed, the cable connecting the IPG to the leads disconnected, and device implantation (or replacement) will proceed normally. Any pacing lead used temporarily would be removed if not required for ongoing patient treatment.
Patients will be considered as having completed the study at the conclusion of the acute procedure unless a safety event is observed during the acute procedure in which case the patients will be followed until the event has been resolved.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: ModeratoEligible subjects instrumented for CNT testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is ≥ 18 years of age.
- Subject is indicated for an implant or a replacement with a planned upgrade of a device capable of pacing (pacemaker, ICD, CRT-P, CRT-D).
- Subject is willing and able to comply with the study procedures.
Key exclusion criteria (15 listed)
- Subject is dependent on 100% ventricular pacing.
- Subject has symptoms of heart failure, NYHA Class III or greater
- Subject has an ejection fraction of 25% or less
- Subject's systolic blood pressure is less than 100 mmHg on the day of implant
- Subject has decompensated heart failure
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 |
|---|---|---|
| ModeratoSeveral algorithms comprising CNT will be delivered by the Moderato Implantable Pulse Generator. Each application will last approximately 3 min with 2 minutes baseline (regular pacing) between them. Hence, each subject will serve as its own control (during pacing) and test (during CNT application). Furthermore, the average control value for the whole group will be compared with the average test values of CNT algorithms at the different ventricular lead locations for efficacy assessments. Stratification of subjects by initial hemodynamic parameters (such as Ejection Fraction, for example) would be possible depending on the total number of subjects in each group. | Device | Experimental group |
Primary outcome
Average changes in Systolic Blood Pressure Change
Time frame: through study completion (18 months)
When compared to standard pacing, CNT elicits a reduction in Systolic Blood Pressure (mmHg)
5 secondary outcomes
Average Cardiac Volumes (End Diastolic and End Systolic volumes, stroke volumes)
Time frame: through study completion (18 months)
Average Ejection Fraction (the percent of blood volume ejected per beat)
Time frame: through study completion (18 months)
Average Cardiac Pressures (End Systolic and Diastolic Pressures)
Time frame: through study completion (18 months)
Average cardiac contractility
Time frame: through study completion (18 months)
Average Systemic Vascular Resistance
Time frame: through study completion (18 months)
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 22 Jun 2026.
- Background: PubMed 17853871Klotz S, Dickstein ML, Burkhoff D. A computational method of prediction of the end-diastolic pressure-volume relationship by single beat. Nat Protoc. 2007;2(9):2152-8. doi: 10.1038/nprot.2007.270.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 34387126Kalarus Z, Merkely B, Neuzil P, Grabowski M, Mitkowski P, Marinskis G, Erglis A, Kazmierczak J, Sturmberger T, Sokal A, Pluta S, Geller L, Osztheimer I, Malek F, Kolodzinska A, Mika Y, Evans SJ, Hastings HM, Burkhoff D, Kuck KH. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study. J Am Heart Assoc. 2021 Aug 17;10(16):e020492. doi: 10.1161/JAHA.120.020492. Epub 2021 Aug 13.
- Individual participant dataSharing planned: No
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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.
Marek Jastrzębski,, MD, PhD principal investigator
Jagiellonian University
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 in people with Bradycardia and A-V Block, run by BackBeat Medical Inc at 1 site in Poland.
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 3 inclusion and 15 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 22 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 Poland. 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?
Average changes in Systolic Blood Pressure Change (time frame: through study completion (18 months)). 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 NCT05345925, which also lists 4 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 22 Jun 2026.