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Pacemaker tweak may ease heart failure by calming nerves

NCT ID NCT04573699

Symptom relief Sponsor: BackBeat Medical Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a modified pacemaker in 34 people with heart failure (NYHA class II or III). The device delivers special pacing signals to reduce overactive sympathetic nerve activity, which can strain the heart. Researchers measured changes in arterial elastance, a sign of relaxed blood vessels, to see if the therapy worked safely during a short procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a modified pacemaker that delivers cardiac neuromodulation therapy (CNT) to calm overactive nerves
What this could lead to
If it works, this could lead to a new pacemaker-based therapy that helps heart failure patients feel better and live more comfortably.
What could go wrong
This was a small, early feasibility study with only 34 people, so results may not apply to everyone. The therapy is still experimental and needs much more testing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

34 people

The number who actually took part.

Started

Dec 2020

Finished

Dec 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is ≥ 18 years of age 2. Subject has a primary indication and is scheduled for ICD implantation or replacement 3. Subject has heart failure NYHA Class II or III Exclusion Criteria: 1. Subject is to receive a single chamber defibrillator 2. Subject has an ejection fraction of 25% or less 3. Subject's systolic blood pressure is less than 120 mm Hg on the day of implant 4. Subject has decompensated heart failure 5. Subject has significant (\>2+) mitral regurgitation, aortic regurgitation or aortic stenosis. 6. Subject has permanent atrial fibrillation 7. Subject has atrial fibrillation on the day of the study. 8. Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm 9. 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. 10. Subject has a history of autonomic dysfunction 11. Women who are pregnant or breast-feeding 12. Subject cannot or is unwilling to provide informed consent.

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Conditions

The condition(s) this trial relates to.

mild heart failure moderate heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure nyha class II Heart failure nyha class III

Contacts and locations

Locations

  • Silesian Center for Heart Diseases

    Zabrze, 41-800, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.