RECRUITING Not applicable ClinicalTrials.gov

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

Sponsor: Biotronik, Inc. • ClinicalTrials.gov ID: NCT07118358

Registry updated: 2026-10-16

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Description

The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according to applicable guidelines. An integrated atrioventricular synchrony sub-study (AVS) is specifically designed to evaluate the AVS performance of the LivIQ system.

Interventions

LivIQ Leadless Pacemaker System (Device)
Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.

Eligibility criteria

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

Conditions

Leadless Pacemaker Bradycardia AV Block Cardiac Rhythm Disorder

Locations

Sutter Health — Burlingame, California, United States
UC San Diego Health — La Jolla, California, United States
MemorialCare Saddleback Medical — Laguna Hills, California, United States
Cardiology Associates Medical Group — Ventura, California, United States
South Denver Cardiology — Littleton, Colorado, United States
Orlando Health Heart & Vascular Institute — Orlando, Florida, United States
Sarasota Memorial Health Care System — Sarasota, Florida, United States
Baptist Health Lexington — Lexington, Kentucky, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Trinity Health Michigan Heart — Ypsilanti, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
Washington University — St Louis, Missouri, United States
NYU Heart Rhythm Center — New York, New York, United States
NY Presbyterian Weill Cornell Medicine — New York, New York, United States
Montefiore Medical Center - Moses Division — The Bronx, New York, United States
Advocate/Atrium Health Sanger Heart and Vascular Institute — Charlotte, North Carolina, United States
WakeMed — Raleigh, North Carolina, United States
Wake Forest University Health — Winston-Salem, North Carolina, United States
Cardiology Consultants of Philadelphia — Paoli, Pennsylvania, United States
Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
WellSpan Health York Hospital — York, Pennsylvania, United States
UVA Health University Medical Center — Charlottesville, Virginia, United States
Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
Royal Adelaide Hospital — Adelaide, South Australia, Australia
Victorian Heart Hospital — Clayton, Victoria, Australia
Kepler Universitätsklinikum GmbH — Linz, Austria
AZ Sint-Jan — Bruges, Belgium
Jessa Ziekenhuis — Hasselt, Belgium
UZ Leuven Gasthuisberg — Leuven, Belgium
CHR de la Citadelle - Liège — Liège, Belgium
Hôpital Gabriel Montpied, Clermont Ferrand — Clermont-Ferrand, France
Hôpital Europeén Georges Pompidou — Paris, France
Hôpital Haut Lévêque (CHU) — Pessac, France
Kerckhoff-Klinik GmbH — Bad Nauheim, Hesse, Germany
Herz- und Diabeteszentrum NRW — Bad Oeynhausen, North Rhine-Westphalia, Germany
Heinrich-Heine Universität Düsseldorf — Düsseldorf, Germany
Kokura Memorial Hospital — Kitakyushu, Fukuoka, Japan
National Cerebral and Cardiovascular Center Hospital — Suita, Osaka, Japan
OLVG — Amsterdam, Netherlands
Research & Innovation Heart Centre St. Antonius Ziekenhuis — Nieuwegein, Netherlands
HagaZiekenhuis van Den Haag - Leyweg — The Hague, Netherlands

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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