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Could a simple pacemaker setting ease right heart failure?

NCT ID NCT07470047

Disease control Sponsor: Shanghai Zhongshan Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether setting a pacemaker to a faster rate (90 beats per minute) can help people with right heart failure and severe tricuspid regurgitation. Twenty-four participants with a low resting heart rate will get a special pacemaker implant and be followed for 6 months. The goal is to see if the faster pacing improves heart function, symptoms, and quality of life.

What this could mean

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

Active substance
permanent pacemaker implantation using left bundle branch pacing, set to 90 bpm
What this could lead to
If it works, this could offer a new way to manage right heart failure by simply adjusting heart rate with a pacemaker, potentially improving daily life and reducing symptoms.
What could go wrong
This is a very small, early-stage trial with only 24 people, so results may not apply to everyone. The faster pacing might not be tolerated or could cause side effects like discomfort or arrhythmias.

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 24 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Mean resting heart rate ≤ 65 beats/min (based on a resting electrocardiogram). 2. Clinically confirmed right-sided heart failure, requiring ≥2 diuretic units to fully control edema, or having persistent grade ≥1 edema despite diuretic therapy. Diuretic unit definition: expressed as the number of daily doses at the standard oral dose. For example, the standard units for furosemide, torasemide, and spironolactone are 20 mg/day, 10 mg/day, and 20 mg/day, respectively. If a patient takes furosemide 20 mg twice daily and spironolactone 20 mg once daily, the total diuretic units equal 3. 3. Echocardiography shows severe or greater tricuspid regurgitation. 4. With/without an indication for permanent pacemaker implantation. 5. Is able to understand the purpose of the trial, voluntarily participates and signs written informed consent, and is willing to complete follow-up visits as required by the protocol. Exclusion Criteria: 1. Mean pulmonary artery pressure (mPAP) \> 35 mmHg measured by right heart catheterization at a pacing rate of 60 bpm. 2. Left ventricular ejection fraction (LVEF) \< 50% or left ventricular end-diastolic diameter (LVEDD) \> 56 mm as measured by echocardiography. 3. Prior implantation of a cardiac pacemaker. 4. Moderate or greater left-sided valvular regurgitation or stenosis. 5. Current use of heart rate-lowering medications, such as beta-blockers, digoxin, ivabradine, etc. 6. Untreated hypothyroidism. 7. Participation in another drug or medical device clinical trial that has not yet been completed. 8. Deemed unsuitable for participation in this clinical trial by the investigator.

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Conditions

The condition(s) this trial relates to.

heart failure tricuspid valve insufficiency

As listed by the trial registrant

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

Right 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

    3 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

  • Shanghai Geriatric Medical Center

    Shanghai, Shanghai Municipality, 201104, China

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

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