An interventional study of CNT testing in Hypertension and Bradycardia, sponsored by BackBeat Medical Inc. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by BackBeat Medical Inc · Not applicable, Interventional, and Treatment
After meeting all inclusion/exclusion criteria, subjects on standard pacing with the Moderato® or Moderato Plus Implantable Pulse Generator (IPG) will be subjected to two set-up sessions for the CNT algorithm: at week 4 and at week 6 post implant. At the end of these visits, subjects will undergo a 24 ambulatory blood pressure recording after which CNT will be automatically turned OFF and standard pacing will resume.
The ambulatory data will provide the basis for a lasting CNT programming by week 8. Follow up visits will be scheduled after 3, 6, and 12 months.
This is a feasibility, pilot, interventional clinical study comparing the performance of CNT pacing signals delivered by Moderato® System or Moderato Plus using a new Setup Algorithm to the performance of the CNT pacing signals delivered by Moderato® System in a similar patient population in a previous multi-center, randomized, double blinded chronic trial (MODERATO II, described below).
Subjects meeting all eligibility criteria (detailed below) will receive a Moderato® IPG (Implantable Pulse Generator), either as a new implant or as a replacement to an existing pacemaker (visit 2). The subject will then be observed during the "Run-in Phase" for 30 days with the device programmed to deliver standard pacing therapy. During the "Run-In Phase", 3 weeks from implant (visit 3), the subjects will undergo a 24-hour Ambulatory Blood Pressure Measurement (ABPM). At the end of the "Run-in Phase" (4 weeks from implant at visit 4), eligibility for activation of CNT pacing signals will be re-established. Subjects eligibility will be determined following the result of the 24-hour ABPM conducted at week 3 from implant and office blood measurement at week 4 (inclusion criteria #5) and an assessment of change in ejection fraction from baseline using an echo measurement (exclusion criteria #5).
All subjects will undergo in visits 4 and 5 two sessions to test two different setup CNT Algorithms. One version will favor atrial pacing. The order of the setup versions will alternate, whereby subjects will start with setup version 1 or setup version 2 (see below). They will also undergo setup without the use of an algorithm, similar to the method used in the MODERATO II study.
After the "Run-In Phase", subjects meeting all eligibility criteria will undergo Setup Algorithm 1 (or 2). At the end of the visit, the Moderato® IPG will be programmed with the resulting CNT parameters to be delivered for 24 hours; after which the device will continue as a standard pacemaker with the pre-sets of the "Run-In Phase" period. Subjects will be fitted with 24 hour ABPM devices and sent home.
After two weeks (visit 5), subjects will return for the second setup visit. This time, subjects will undergo setup using the setup Algorithm version that was not used on them in the First Setup visit. They will also undergo setup without use of the algorithm, similar to the method used in the MODERATO II study. At the end of the second setup visit, the Moderato® IPG will be programmed using the resulting CNT parameters, to be delivered for 24 hours; after which the device will continue as a standard pacemaker with the pre-sets of the "Run-In Phase" period. Subjects will be fitted with 24 hour ABPM devices and sent home.
Subjects will return after two weeks for the trial CNT activation visit (visit 6). Based on the effect of the previous test CNT activations on blood pressure established by the two ABPM assessments, the investigator will decide whether to Continue CNT for the patient, with the parameters determined by the first or the second Setup Algorithm, or use the parameters established during setup without use of the algorithm.
Subjects will be further followed 3, 6 and 12 months post CNT activation (5, 8 and 14 months from implant) for changes in blood pressure and any adverse events (see study duration below).
At the end of the follow-up period, the treating physician will decide whether to leave CNT therapy on or off. Patient care will continue according to existing best practices.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →BackBeat Medical Inc is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
When performing the Setup Algorithm Version 1, each subject's blood pressure is measured with a standard cuff system while the BackBeat-CNT is activated, and system parameters are varied successively according to a specified sequence or based on the blood pressure measurements obtained during previous activations of BackBeat CNT, until the Setup Algorithm is complete. The parameter values as determined by the Setup Algorithm will constitute the programming of the Moderato IPG for the 24 hour activation following setup.
Device: CNT testing
When performing the Setup Algorithm Version 1, each subject's blood pressure is measured with a standard cuff system while the BackBeat-CNT is activated, and system parameters are varied successively according to a specified sequence or based on the blood pressure measurements obtained during previous activations of BackBeat CNT, until the Setup Algorithm is complete. The parameter values as determined by the Setup Algorithm will constitute the programming of the Moderato IPG for the 24 hour activation following setup.
Device: CNT testing
For this optimization procedure, each subject's blood pressure is measured with a continuous blood pressure measurement system while the BackBeat-CNT is activated, and system parameters are varied according to a specified sequence until the desired blood pressure reduction is achieved. The parameter values that provide the desired blood pressure reduction will be recorded, for possible use by the investigator following trial completion
Device: CNT testing
The effect of CNT on blood pressure will be obtained throughout the year long follow up period.
CNT efficacy: Changes in average 24 hour systolic ambulatory blood pressure
The change in the 24 hr blood pressure recording after each of the two set up sessions (week 4 and week 6) will be compared to the 24 hr ambulatory data of the control (week 3).
Time frame: up to 12 Month follow-up visit
CNT safety: Incidence of device- and treatment-related adverse and serious adverse
Incidence of device- and treatment-related adverse and serious adverse events during the study.
Time frame: up to 12 Month follow-up visit
Not enrolling at this site.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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