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New pacing technique may shield heart from damage in block patients

NCT ID NCT04624763

Disease control Sponsor: The First Affiliated Hospital with Nanjing Medical University Source: ClinicalTrials.gov ↗

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 if a newer pacing method called left bundle branch pacing (LBBP) is better than standard right ventricular pacing (RVP) at preserving heart function in 683 adults with atrioventricular block (a type of heart block). Participants will be randomly assigned to one of the two pacing methods and followed for at least 3 years. The goal is to see if LBBP reduces the risk of death, heart failure, or pacing-related heart damage.

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 683 people

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

Started

Jun 2021

Expected to finish

Jan 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: 1. Indication of permanent pacemaker implantation: (1) Second degree or complete AV block; (2) Persistent or permanent atrial fibrillation with mean ventricular rate \< 50 bpm and related symptoms 2. LVEF \> 35%, NYHA classification I-III 3. Age \> 18 years 4. Signed informed consent Exclusion Criteria: 1. Implanted prosthetic tricuspid valve 2. Unstable angina, acute myocardial infarction, CABG or PCI within the last 3 months 3. Cardiac surgery like valvular replacement, TAVI, ventricular septal myectomy or ablation within the last 3 months 4. Enrolled in any other study 5. A life expectancy of less than 12 months or unable to undergo the planned 6. follow-up for any reasons 6. Pregnant or with a child-bearing plan 7. A history of heart transplantation 8. Complex congenital heart disease (whether surgical correction or not) and post-surgery repair or post-closure of ventricular septal defect 9. Ventricular septal hypertrophy (≥ 15mm during diastole) 10. Isolated persistent left superior vena cava 11. With ICD, CRT or CRTD indications 12. Pacemaker replacement, upgrade and pocket infection needing re-implantation

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Conditions

The condition(s) this trial relates to.

atrioventricular block

As listed by the trial registrant

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

Atrioventricular block

Contacts and locations

Locations

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029, China

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