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New heart lead aims to improve pacing for slow heartbeat

NCT ID NCT06540079

Disease control Sponsor: Biotronik, Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Updated 2 times

Summary

This study tests a new pacing lead (Solia CSP S) placed deep in the heart to treat slow heart rhythms. About 192 people with heart block or sinus node problems will get the lead. The main goals are to check safety (no serious device issues in 3 months) and how often the lead is placed correctly.

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

192 people

The number who actually took part.

Started

Dec 2024

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and CRT-P systems are allowed. * Patient has an implant planned to utilize left bundle branch area (LBBA) pacing within 30 days of consent * Patient is able to understand the nature of the study and provide written informed consent * Patient is available for follow-up visits on a regular basis for the expected duration of follow-up * Patient accepts Home Monitoring® concept * Patient age is greater than or equal to 18 years at time of consent Exclusion Criteria: * Patient meets a standard contraindication for pacemaker system implant * Patient is currently implanted with a pacemaker or ICD device * Patient has had a previous unsuccessful attempt to place a lead in the LBBA * Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant * Patient is expected to receive a heart transplant within 12 months * Patient life expectancy less than 12 months * Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder * Patient reports pregnancy at the time of enrollment * Patient is enrolled in any other investigational cardiac clinical study during the course of the study

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Conditions

The condition(s) this trial relates to.

atrioventricular block Bradycardia sick sinus syndrome sinoatrial node disorder

As listed by the trial registrant

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

Atrioventricular block Bradycardia Sinus node dysfunction

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Banner - University Medical Center Phoenix

    Phoenix, Arizona, 85006, United States

  • Cardiology Associates Medical Group

    Ventura, California, 93003, United States

  • Cardiology Associates Research, LLC

    Tupelo, Mississippi, 38801, United States

  • Cardiology Consultants of Philadelphia

    Paoli, Pennsylvania, 19301, United States

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711, United States

  • NYU Heart Rhythm Center

    New York, New York, 10016, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • Weill Cornell Medicine

    New York, New York, 10021, United States

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