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New pacing lead aims to improve heartbeat in patients with slow heart rate

NCT ID NCT07217392

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new type of heart pacing lead that is placed in the left bundle branch area, a key part of the heart's electrical system. The goal is to see if this approach is safe and works better than standard pacing for people with bradycardia (slow heart rate) or heart failure. About 200 participants will be followed for 6 months after getting the lead implanted.

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 pacing lead (a special heart pacing wire)
What this could lead to
If successful, this could offer a more natural and effective way to pace the heart, potentially reducing complications from traditional pacing.
What could go wrong
This is an early-stage study focused on safety and device performance, not a cure. Risks include infection, heart injury, or lead malfunction. The benefits over standard pacing are not yet proven.

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 200 people

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

Started

Jul 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

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: 1. Meets current clinical practice guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area 2. Are ≥ 18 years of age or age of legal consent, whichever age is greater. 3. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams. 4. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC. Exclusion Criteria: 1. Patient meets a standard contraindication for lead implant including: 1. the presence of tricuspid atresia 2. patients with mechanical tricuspid valves 3. patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate 2. Patient is currently implanted with a pacemaker, ICD, or CRT-D/P device 3. Patient has had a previous unsuccessful attempt to place a lead in the LBB area 4. Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant 5. Patient is expected to receive a heart transplant within 6 months 6. Patient life expectancy less than 6 months 7. Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder 8. Patient is enrolled or planning to enroll in another clinical trial that might confound the results of the present study 9. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. 10. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Bradycardia heart disorder heart failure

As listed by the trial registrant

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

Atrial fibrillation (AF) Bradycardia Cardiac disease Conduction system pacing Heart failure Left bundle branch area pacing Right ventricular pacing

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites in 7 countries. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Changi General Hospital

    NOT_YET_RECRUITING

    Singapore, Central, 529889, Singapore

  • Fortis Escorts Heart Institute

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110025, India

  • Hopital d'adulte de la Timone

    RECRUITING

    Marseille, Alpes, 13005, France

  • Hospital Universitario Doce de Octubre

    NOT_YET_RECRUITING

    Madrid, Madrid, 28041, Spain

  • Institut Jantung Negara

    NOT_YET_RECRUITING

    Kuala Lumpur, Cmalays, 50400, Malaysia

  • Instituto Nacional de Cardiologia (INC)

    NOT_YET_RECRUITING

    Rio de Janeiro, Rio de Janeiro, 22240-006, Brazil

  • Instituto do Coracao (InCor) - HCFMUSP

    NOT_YET_RECRUITING

    São Paulo, São Paulo, 05403-000, Brazil

  • Kerckhoff-Klinik gGmbH

    NOT_YET_RECRUITING

    Bad Nauheim, Hesse, 61231, Germany

  • Manipal Hospital E.M. Bypass

    NOT_YET_RECRUITING

    Kolkata, West Bengal, 700099, India

  • Meenakshi Mission Hospital & Research Centre

    RECRUITING

    Madurai, Tamil Nadu, 625107, India

  • Narayana Institute of Cardiac Sciences, Bommasandra

    RECRUITING

    Bangalore, Karnakt, 560099, India

  • Tan Tock Seng Hospital

    RECRUITING

    Singapore, Central, 308433, Singapore

  • Vardhman Mahavir Medical College & Safdarjung Hospital

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110029, India

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