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Could a simple pacemaker tweak ease heart failure?

NCT ID NCT07563153

Symptom relief Sponsor: Samsung Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adjusting a pacemaker's lower heart rate to an individual's optimal level can improve symptoms and quality of life in people with heart failure and bradycardia. Researchers will compare this personalized approach to the standard fixed rate of 60 beats per minute. The trial involves 106 participants and will measure symptom changes over 12 months using a heart failure questionnaire.

What this could mean

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

Active substance
Adjustment of pacemaker lower rate limit
What this could lead to
If successful, this could provide a simple, non-drug way to improve heart failure symptoms and quality of life for people who need a pacemaker.
What could go wrong
This is a small, early-stage trial (106 participants) testing a device setting change, not a new therapy. The benefit may be modest or not apply to all heart failure patients.

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 106 people

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

Started

Dec 2025

Expected to finish

Dec 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

19 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: * Patients with symptomatic bradycardia who meet the indication for permanent pacemaker implantation and fulfill one of the following conditions: 1. Sick sinus syndrome with or without impaired atrioventricular conduction 2. Persistent or permanent atrial fibrillation with slow ventricular response 3. Chronotropic incompetence * Patients diagnosed with heart failure with left ventricular ejection fraction ≥ 50% on transthoracic echocardiography with at least one of the following: * H2FPEF score ≥ 6 or HFA-PEFF score ≥ 5 * N-terminal pro-B-type natriuretic peptide ≥ 300 pg/mL (sinus rhythm) or ≥ 600 pg/mL (atrial fibrillation) * Prior hospitalization for heart failure or documented use of loop diuretics for heart failure symptoms Exclusion Criteria: * Patients expected to have a ventricular pacing burden ≥ 20% without sufficient capture of cardiac physiologic pacing, which includes biventricular pacing, His bundle pacing, and left bundle branch area pacing. (Sufficient cardiac physiologic pacing is defined as a paced QRS duration ≤ 140 ms.) * Patients not expected to achieve sufficient pacing dependency, defined as: 1. In sinus rhythm: baseline atrial rate \> 60 bpm on Holter monitoring or inpatient ECG monitoring 2. In atrial fibrillation/flutter: baseline ventricular rate \> 60 bpm on Holter monitoring or inpatient ECG monitoring * Patients with contraindications to permanent pacemaker implantation * Patients with moderate or greater valvular stenosis or regurgitation. * Patients with dyspnea not attributable to heart failure, due to uncontrolled comorbid conditions * Pregnant or breastfeeding women. * Patients who have refused active treatment.

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Conditions

The condition(s) this trial relates to.

Bradycardia diastolic heart failure heart failure

As listed by the trial registrant

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

Bradycardia Heart failure

How to take part

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

  1. The places running it

    1 site. 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

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul, 06351, South Korea

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