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New pacemaker lead aims to improve heart function in bradycardia patients

NCT ID NCT06011252

Disease control Sponsor: Chang Gung Memorial 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This study tests a special pacing lead placed in the left bundle branch area of the heart for people with symptomatic bradycardia (slow heartbeat). The goal is to see if this approach works well, is safe, and provides stable pacing over 12 months. About 134 adults who need a new pacemaker will take part, and researchers will monitor success rates, heart function, and any complications.

What this could mean

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

Active substance
Solia S pacing lead with BIOTRONIK pacemaker
What this could lead to
If successful, this could offer a more effective and safer pacing method for people with slow heartbeats, reducing heart damage from traditional pacing.
What could go wrong
This is an early-stage, single-arm study with no comparison group, so results may not apply to all patients. The procedure carries standard risks like infection or lead displacement.

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

134 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Jun 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

20 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: * Adult patients ≥ 20 years of age * Standard bradycardia pacing indications requiring new ventricular lead implantation * Able to give informed consent for the participation in the trial Exclusion Criteria: * Patients underwent cardiac resynchronization therapy or implantable cardioverter-defibrillator implantation * New York Heart Association (NYHA) functional class IV heart failure * Life expectancy \< 1 year * Right-sided approach for lead implantation * Hemodialysis or peritoneal dialysis patients * Pregnant or breast-feeding women * Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints * Participation in another prospective interventional clinical study within a period of 4 weeks prior to the implantation of LBBAP * Use of any recreational drugs or history of drug addiction * Any other condition that, in the investigator's judgment, might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study

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As listed by the trial registrant

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

Symptomatic bradycardia

Contacts and locations

Locations

  • Chang Gung Memorial Hospital

    Linkou District, Taipei, 10507, Taiwan

  • Chang Gung Memorial Hospital

    Kaohsiung City, Taiwan

  • China Medical University Hospital

    Taichung, Taiwan

  • MacKay Memorial Hospital

    Taipei, Taiwan

  • National Yang Ming Chiao Tung University Hospital

    Yilan, Taiwan

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