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New pacing technique aims to stop irregular heartbeat in heart failure patients

NCT ID NCT07547449

Disease control Sponsor: Fu Wai Hospital, Beijing, China Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a special pacing method called Bachmann bundle pacing can prevent new atrial fibrillation (a type of irregular heartbeat) in people with heart failure who already need a pacemaker or defibrillator. About 110 participants will be randomly assigned to receive either this new pacing or standard pacing, and all will continue their usual heart failure medications. The main goal is to see how many develop atrial fibrillation within 12 months after the device is implanted.

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 140 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 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 to 70 years

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. Aged between 18 and 70 years old; 2. Diagnosis of chronic cardiac insufficiency according to current guidelines, and received guideline-directed medical therapy (GDMT) for at least 3 months; 3. Have indications for CRT/LBBP or ICD implantation, and expected atrial pacing ratio \> 20%, including: Sinus rhythm, QRS duration \> 120ms, LBBB, LVEF ≤ 35% with symptomatic heart failure; Sinus rhythm, QRS duration ≥ 150ms, non-LBBB, LVEF ≤ 35% with symptomatic heart failure; Sinus rhythm, QRS duration \> 120ms, LBBB, LVEF 36%-50% with symptomatic heart failure; Symptomatic heart failure with LVEF ≤ 50% and expected ventricular pacing ratio \> 20%; Symptomatic heart failure with LVEF ≤ 50% requiring ICD implantation for primary or secondary sudden death prevention, with atrial pacing indication due to sinus bradycardia or expected atrial pacing ratio \> 20%; 4. Patients with pacing-induced cardiomyopathy requiring upgrade therapy, in sinus rhythm, and requiring reimplantation of atrial lead; 5. Signed written informed consent form approved by the ethics committee. Exclusion Criteria: 1. Expected survival time less than 12 months; 2. Status after mechanical tricuspid valve replacement, or congenital heart disease (including dextrocardia, transposition of great arteries, single left persistent superior vena cava); 3. Previous history of atrial fibrillation; 4. Previous cardiac surgery, or requiring surgical treatment for severe structural heart disease within 1 year; 5. Pregnancy, planned pregnancy, or heart transplantation; 6. Patient refusal to participate in the study.

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Conditions

The condition(s) this trial relates to.

heart failure atrial fibrillation prevention target

As listed by the trial registrant

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

Atrial fibrillation (AF) Cardiac insufficiency Heart failure

How to take part

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  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

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Contacts and locations

Locations

  • Fuwai Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037, China

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