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Could a smarter pacemaker setting sharpen the mind?

NCT ID NCT07769424

Disease control Sponsor: University of Minnesota 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This trial asks whether tailoring a pacemaker's lower heart rate to each person—rather than using a standard fixed rate—can improve cognitive function and overall health status in people with symptomatic bradycardia (a heart rate that is too slow). About 110 adults who need a permanent pacemaker will be randomly assigned to either standard programming at 60 beats per minute or individualized physiologic pacing between 60 and 90 beats per minute using the myPACE algorithm. Thinking ability and quality of life are measured before implantation and again at the routine 3-month follow-up visit.

What this could mean

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

Active substance
Physiologic pacemaker programming using the myPACE algorithm, which adjusts heart rate between 60 and 90 beats per minute, compared to standard programming at 60 beats per minute.
What this could lead to
If personalized pacemaker settings improve cognitive function and quality of life, this could point toward a simple programming change to help many pacemaker patients think and feel better.
What could go wrong
This is an early proof-of-concept study, so results may not be definitive or apply to all patients. The intervention only adjusts pacemaker settings, and benefits may be modest or vary by individual.

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

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: \- Patient requiring a pacemaker for bradycardia Exclusion Criteria: * Vulnerable adult unable to give consent * Unable to answer questionnaire * Children * Pregnant women/persons * Prisoners * Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent * Non-English speakers * Individuals unable to read * Employees or students of the researcher * Active members of the military or DoD personnel

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As listed by the trial registrant

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

Cognitive function Health status Pacemaker Symptomatic bradycardia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M Health Fairview Clinics and Surgery Center

    Minneapolis, Minnesota, 55455, United States

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

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