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Pacemaker tweak may lower blood pressure in early test

NCT ID NCT05345925

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small, completed study tested whether special pacing signals from a pacemaker could help control blood pressure in people with slow heartbeats. Five adults who needed a pacemaker or similar device took part. Researchers measured blood pressure and heart function during brief periods of the special pacing and compared them to standard pacing.

What this could mean

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

Active substance
Cardiac neuromodulation therapy (CNT) pacing signals delivered by a pacemaker device
What this could lead to
If successful, this could lead to a new way to manage blood pressure in people who already need a pacemaker.
What could go wrong
This was a very small, short-term study with only 5 participants. It only measured immediate effects, not long-term safety or benefits. The results may not apply to everyone.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5 people

The number who actually took part.

Started

May 2023

Finished

Nov 2023

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.

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: * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

atrioventricular block Bradycardia

As listed by the trial registrant

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

A-V block Bradycardia

Contacts and locations

Locations

  • University Hospital, Jagiellonian University

    Krakow, 30-688, Poland

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