An observational study in Heart Failure NYHA Class II and Heart Failure NYHA Class III, sponsored by BackBeat Medical Inc. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by BackBeat Medical Inc · Observational
This investigation will evaluate the ability of the Moderato® System to safely and effectively deliver CNT, to reduce sympathetic activity in heart failure patients
This will be a single center, non-randomized observational study. The Moderato® System is approved for marketing in Europe (has a CE mark) for 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). Heart failure patients is a population for which the Moderato® device is currently not indicated.
Subjects requiring an implantable cardiac defibrillator (ICD) implantation or replacement and meeting study inclusion and exclusion criteria will be eligible to participate in the study. The study procedure will take place during the ICD implantation (or replacement).
The whole procedure will be performed according to standard of care for ICD implantations (or replacements) including periprocedural prophylactic antibiotics prophylactic. To reduce the time of wound exposure, the setup of system for invasive measurements will be done before the ICD implant (or replacement) procedure begins.
The groin area will be prepared and draped. After applying local anesthesia, a 7Fr sheath will be inserted into the femoral artery. A small dose of heparin (\~5000 units) will be administered intravenously to prevent formation of blood clots. Under fluoroscopic guidance, a standard conductance catheter (CD Leycom CA-71103-PL, CE marked) will be advanced into the left ventricle.
The arterial line will be used to measure arterial pressure. This completes the measuring system setup.
Then, ICD right atrial lead and right ventricular lead will be implanted in standard positions according to standard institutional practices.
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, 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.
A range of CNT signal parameters will be used to assess the effect on sympathetic activity. 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 over a period of time no longer than one hour.
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 ICD 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 ICD implantation will proceed normally.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 34 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure 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.
These are Heart Failure subjects willing to participate in a short acute clinical study during the implantation or replacement of a single chamber ICD.
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 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.
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.
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.
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.
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.
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.
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.
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.
A modified CNT, will be delivered as a pacing sequence able to acutely influence sympathetic tone.
Change in Arterial Elastance
Arterial elastance is reduced when sympathetic activity is reduced, an indication of a relaxed peripheral resistance.
Time frame: Immediate, derived form ongoing Pressure Volume changes in the Left ventricle
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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