AzTrials
AzTrials

Heart Failure NYHA Class IINCT04573699

Cardiac Neuromodulation for Heart Failure

An observational study of Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by BackBeat Medical Inc at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This investigation will evaluate the ability of the Moderato® System to safely and effectively deliver CNT, to reduce sympathetic activity in heart failure patients Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CNT-HF
Type of treatment
Medical device
How many people
34 participants
Where
1 sitePoland
Study dates
15 Dec 2020to 15 Dec 2022
Phase
Observational
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

Study population: These are Heart Failure subjects willing to participate in a short acute clinical study during the implantation or replacement of a single chamber ICD.

Who may be able to join

  • Subject is ≥ 18 years of age
  • Subject has a primary indication and is scheduled for ICD implantation or replacement
  • Subject has heart failure NYHA Class II or III

Who cannot join

  • Subject is to receive a single chamber defibrillator
  • Subject has an ejection fraction of 25% or less
  • Subject's systolic blood pressure is less than 120 mm Hg on the day of implant
  • Subject has decompensated heart failure
  • Subject has significant (>2+) mitral regurgitation, aortic regurgitation or aortic stenosis.
  • Subject has permanent atrial fibrillation
Show all 12Show fewer
  • Subject has atrial fibrillation on the day of the study.
  • Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
  • 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.

Poland1 site

  • Silesian Center for Heart Diseases

    Zabrze, 41-800

Other trials in Poland

About this study

Official title: BackBeat Medical Cardiac Neuromodulation Therapy in Patients With Heart Failure: An Acute Feasibility Study

This investigation will evaluate the ability of the Moderato® System to safely and effectively deliver CNT, to reduce sympathetic activity in heart failure patients

Read the detailed description

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.

Being tested
CNT-HF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CNT-HFDevice

    A modified CNT, will be delivered as a pacing sequence able to acutely influence sympathetic tone.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Arterial Elastance

    Arterial elastance is reduced when sympathetic activity is reduced, an indication of a relaxed peripheral resistance.

    Measured: Immediate, derived form ongoing Pressure Volume changes in the Left ventricle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start15 Dec 2020
  3. Primary completion15 Dec 2022
  4. Study completion15 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04573699
Sponsor's protocol ID
BBM HF-CS-01
Status last verified
Jun 2026
First submitted
28 Sep 2020
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur J Heart Fail. 2008 Oct;10(10):933-89. doi: 10.1016/j.ejheart.2008.08.005. Epub 2008 Sep 16. No abstract available.

    PubMed 18826876

  • Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):188-97. doi: 10.1161/CIR.0b013e3182456d46. No abstract available.

    PubMed 22215894

  • van Bilsen M, Patel HC, Bauersachs J, Bohm M, Borggrefe M, Brutsaert D, Coats AJS, de Boer RA, de Keulenaer GW, Filippatos GS, Floras J, Grassi G, Jankowska EA, Kornet L, Lunde IG, Maack C, Mahfoud F, Pollesello P, Ponikowski P, Ruschitzka F, Sabbah HN, Schultz HD, Seferovic P, Slart RHJA, Taggart P, Tocchetti CG, Van Laake LW, Zannad F, Heymans S, Lyon AR. The autonomic nervous system as a therapeutic target in heart failure: a scientific position statement from the Translational Research Committee of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2017 Nov;19(11):1361-1378. doi: 10.1002/ejhf.921. Epub 2017 Sep 26.

    PubMed 28949064

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure NYHA Class II and Heart Failure NYHA Class III, 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 12 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 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?

Change in Arterial Elastance (time frame: Immediate, derived form ongoing Pressure Volume changes in the Left ventricle). 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 NCT04573699, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in