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Tiny pacemaker, no wires: new trial tests LivIQ for heart rhythm control

NCT ID NCT07118358

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This study is testing a new, wire-free pacemaker called LivIQ in 325 people who need a pacemaker for a slow heartbeat. The goal is to see if it is safe and works well to keep the heart beating at the right pace. Participants will be followed for several months to check the device's performance and any side effects.

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 325 people

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

Started

Mar 2026

Expected to finish

Apr 2028

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. Class I or Class II indication for ventricular pacing (VVI/VDD) according to applicable guidelines 2. Age is greater than or equal to 18 years at time of consent 3. Able to understand the nature of the study and provide written informed consent 4. Able and willing to complete all study requirements, including completion of all planned in-office study visits, for the expected duration of follow-up Exclusion criteria: 1. AV block with a ventricular escape rhythm ≤ 30 bpm at time of consent Note: Restriction removed after early safety phase objectives are met 2. Femoral venous anatomy that is unable to accommodate the introducer or the cardiac anatomy does not allow a leadless pacemaker in the right ventricle 3. Morbid obesity which may prevent the LivIQ device from obtaining telemetry communication within a range of 20 cm, in the physician's judgement 4. Intolerance of dexamethasone acetate 5. Other implanted devices that, in the judgement of the implanting physician, could interfere (mechanically or electrically) with the leadless pacemaker or with the implant procedure 6. Allergy to the materials of the leadless pacemaker or the implant tools that are in contact with the human body 7. Prior leadless pacemaker implant attempt 8. Existing transvenous or leadless pacemaker, transvenous or subcutaneous ICD, or CRT device or previous extraction in which transvenous leads (full or partial) were left in the heart Note: Exception given to use temporary transvenous pacemakers 9. CIED device extraction within the previous 72 hours or signs of active infection after CIED extraction Note: Patients with extraction due to potential systemic infection must have a blood culture. A blood culture is considered negative if there is no growth within 72 hours prior to the LivIQ implant. 10. Planned ICD or CRT device implant 11. Unstable angina pectoris or acute myocardial infarction within 30 days prior to enrollment 12. Life expectancy of less than 12 months 13. Unable to tolerate an urgent sternotomy 14. Planned right-sided heart intervention within 30 days after implant Note: Exception given to AV nodal ablations when performed by an implanting investigator once early safety phase objectives are met 15. Listed for or has received a heart transplantation or has a left ventricular assist device (LVAD) 16. Participation or plan to participate in any other potentially confounding investigational drug or device trial, or any other clinical trial that may interfere with this study's treatment or protocol during the duration of the study Note: Co-enrollment in concurrent trials is only allowed when documented prior approval is obtained from BIOTRONIK 17. Unable to attend in-person planned or emergent study site visits (e.g., frequent or extended travel plans) 18. Pregnant or plan to become pregnant during the duration of the study AVS Sub-Study Inclusion Criteria: After consenting to the main study, patients potentially eligible for the AVS Sub-Study must meet these additional criteria: 1. Willing and able to perform the requested procedures for the AVS assessments 2. Current or history of AV block Note: This includes patients with any degree or type of AV block, irrespective of related symptoms and relevance of the AV block for the underlying pacemaker indication AVS Sub-Study Exclusion Criteria: After consenting to the main study, patients potentially eligible for the AVS Sub-Study must not meet the following criterion: 1\. Permanent AF

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrioventricular block Bradycardia cardiac rhythm disease

As listed by the trial registrant

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

Av block Bradycardia Cardiac rhythm disorder Leadless pacemaker

How to take part

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

  1. The places running it

    34 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

  • AZ Sint-Jan

    RECRUITING

    Bruges, 8000, Belgium

  • Advocate/Atrium Health Sanger Heart and Vascular Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Aurora St. Luke's Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Baptist Health Lexington

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • CHR de la Citadelle - Liège

    RECRUITING

    Liège, 4000, Belgium

  • Cardiology Associates Medical Group

    RECRUITING

    Ventura, California, 93003, United States

  • Cardiology Consultants of Philadelphia

    RECRUITING

    Paoli, Pennsylvania, 19301, United States

  • HagaZiekenhuis van Den Haag - Leyweg

    RECRUITING

    The Hague, 2545, Netherlands

  • Heinrich-Heine Universität Düsseldorf

    RECRUITING

    Düsseldorf, 40225, Germany

  • Herz- und Diabeteszentrum NRW

    RECRUITING

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

  • Hôpital Europeén Georges Pompidou

    RECRUITING

    Paris, 75908, France

  • Hôpital Gabriel Montpied, Clermont Ferrand

    RECRUITING

    Clermont-Ferrand, BP69-63003, France

  • Hôpital Haut Lévêque (CHU)

    RECRUITING

    Pessac, 33600, France

  • Jessa Ziekenhuis

    RECRUITING

    Hasselt, 3500, Belgium

  • Kepler Universitätsklinikum GmbH

    RECRUITING

    Linz, 4021, Austria

  • Kerckhoff-Klinik GmbH

    RECRUITING

    Bad Nauheim, Hesse, 61231, Germany

  • Kokura Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Kitakyushu, Fukuoka, 802-8555, Japan

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MemorialCare Saddleback Medical

    RECRUITING

    Laguna Hills, California, 92653, United States

  • NY Presbyterian Weill Cornell Medicine

    RECRUITING

    New York, New York, 10021, United States

  • NYU Heart Rhythm Center

    RECRUITING

    New York, New York, 10016, United States

  • National Cerebral and Cardiovascular Center Hospital

    ACTIVE_NOT_RECRUITING

    Suita, Osaka, 564-8565, Japan

  • OLVG

    RECRUITING

    Amsterdam, 1090, Netherlands

  • Orlando Health Heart & Vascular Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Penn Presbyterian Medical Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Research & Innovation Heart Centre St. Antonius Ziekenhuis

    RECRUITING

    Nieuwegein, 3435 CM, Netherlands

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Sarasota Memorial Health Care System

    RECRUITING

    Sarasota, Florida, 34239, United States

  • South Denver Cardiology

    RECRUITING

    Littleton, Colorado, 80120, United States

  • Sutter Health

    RECRUITING

    Burlingame, California, 94010, United States

  • Trinity Health Michigan Heart

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • UVA Health University Medical Center

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • UZ Leuven Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • Victorian Heart Hospital

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Wake Forest University Health

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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