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New pacemaker technique aims to prevent heart damage

NCT ID NCT05869500

Disease control Sponsor: Massachusetts General 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 14, 2026 · Updated 4 times

Summary

This study compares a newer pacing method called left bundle branch area pacing (LBBAP) with standard right ventricular pacing in 100 adults who need a pacemaker but have normal heart function. The goal is to see if LBBAP better prevents the decline in heart pumping ability that can occur with standard pacing. Participants will be randomly assigned to receive one of the two pacemaker types and followed for changes in heart function.

What this could mean

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

Active substance
Left bundle branch area pacemaker (device) vs. right ventricular pacemaker (device)
What this could lead to
If successful, this could show that left bundle area pacing is a better standard option for preventing heart damage in people who need a pacemaker.
What could go wrong
This is a relatively small, early-stage study (100 participants) comparing two device approaches. The procedure for left bundle area pacing is newer and may have higher technical difficulty or unknown long-term risks.

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 100 people

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

Started

May 2023

Expected to finish

Aug 2026

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. Age \>18 2. Patients with complete AV block, high-grade AV block with an anticipated ventricular pacing rate of more than 40% 3. Left ventricular ejection fraction of 50% or more. 4. Echocardiogram within the last 3 months Exclusion Criteria: 1. History of systolic dysfunction with LV EF of less than 50% 2. Prior myocardial infarction 3. Obstructive coronary artery disease 4. Severe valvular dysfunction 5. Life expectancy of less than a year 6. Pregnancy

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Conditions

The condition(s) this trial relates to.

atrioventricular block third-degree atrioventricular block

As listed by the trial registrant

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

Left bundle branch area pacing

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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