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NCT07118358NARecruiting

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

Biotronik, Inc.

Start Date

3/16/2026

Completion Date

4/1/2028

Summary

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.

Detailed Description

BIO-LivIQ is designed as an open-label, prospective, single-arm, multi-center, international study. A total of 325 subjects will be enrolled across up to 60 centers from the U.S., Europe, and Asia Pacific. Within the study, identified patients will be enrolled after a medical record review to determine if all inclusion criteria and no exclusion criteria are met. Once informed consent is obtained, subjects will be examined on-site at enrollment, implant, pre-hospital discharge, 1 month, 3 months, 6 months and 12 months , with continued in-person follow-up every 6 months until regional market approval. After U.S. market approval, a required remote 24-month visit will be conducted to assess vital status. The performance of VDD pacing will be evaluated in the AVS sub-study. Once informed consent is obtained for this sub-study, AVS Holter data will be collected at 1-month and 6-month follow-ups.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

LivIQ Leadless Pacemaker System

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Conditions

Leadless PacemakerBradycardiaAV BlockCardiac Rhythm Disorder

Locations

Sutter Health

Burlingame, California 94010

United States

MemorialCare Saddleback Medical

Laguna Hills, California 92653

United States

Trinity Health Ann Arbor Hospital

Ypsilanti, Michigan 48197

United States

NY Presbyterian Weill Cornell Medicine

New York, New York 10021

United States

Wake Forest University Health

Winston-Salem, North Carolina 27157

United States

Cardiology Consultants of Philadelphia

Paoli, Pennsylvania 19301

United States

UVA Health University Medical Center

Charlottesville, Virginia 22903

United States

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

Victorian Heart Hospital

Clayton, Victoria 3168

Australia

AZ Sint-Jan

Bruges, 8000

Belgium

Jessa Ziekenhuis

Hasselt, 3500

Belgium

UZ Leuven Gasthuisberg

Leuven, 3000

Belgium

CHR de la Citadelle - Liège

Liège, 4000

Belgium

Hôpital Gabriel Montpied, Clermont Ferrand

Clermont-Ferrand, BP69-63003

France

Hôpital Europeén Georges Pompidou

Paris, 75908

France

Hôpital Haut Lévêque (CHU)

Pessac, 33600

France

Kerckhoff-Klinik GmbH

Bad Nauheim, Hesse 61231

Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia 32545

Germany

Heinrich-Heine Universität Düsseldorf

Düsseldorf, 40225

Germany

Kokura Memorial Hospital

Kitakyushu, Fukuoka 802-8555

Japan

National Cerebral and Cardiovascular Center Hospital

Suita, Osaka 564-8565

Japan

Research & Innovation Heart Centre St. Antonius Ziekenhuis

Nieuwegein, 3435 CM

Netherlands

HagaZiekenhuis van Den Haag - Leyweg

The Hague, 2545

Netherlands