BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
BIO-LivIQ
1 other identifier
interventional
325
7 countries
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2025
CompletedFirst Posted
Study publicly available on registry
August 12, 2025
CompletedStudy Start
First participant enrolled
March 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
July 30, 2026
June 1, 2026
12 months
July 15, 2025
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Freedom from Serious Adverse Device Effects
Demonstrate that the freedom from SADEs related to the LivIQ system and/or procedure through 3-month follow-up exceeds the performance goal.
3 months
Percentage of Subjects with Adequate Pacing
Demonstrate that the percentage of subjects with adequate and stable pacing at the 3-month follow-up visit exceeds the performance goal.
3 months
Percentage of Subjects with Adequate Pacing and Sensing
Demonstrate that the percentage of subjects with adequate pacing and sensing at the 3-month follow-up visit exceeds the performance goal.
3 months
Secondary Outcomes (10)
Improvement in SF-36 Role Physical Scale
Baseline and 6 months
Ventricular Capture Control Operation
3 months
Rate Response Operation
3 months
SADEs Related to the LivIQ System and/or Procedure
3, 6, 12 months
Pacing Performance
6, 12 months
- +5 more secondary outcomes
Study Arms (1)
Non randomized arm
OTHERSingle Arm
Interventions
Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.
Eligibility Criteria
You may qualify if:
- Class I or Class II indication for ventricular pacing (VVI/VDD) according to applicable guidelines
- Age is greater than or equal to 18 years at time of consent
- Able to understand the nature of the study and provide written informed consent
- Able and willing to complete all study requirements, including completion of all planned in-office study visits, for the expected duration of follow-up
You may not qualify if:
- AV block with a ventricular escape rhythm ≤ 30 bpm at time of consent Note: Restriction removed after early safety phase objectives are met
- Femoral venous anatomy that is unable to accommodate the introducer or the cardiac anatomy does not allow a leadless pacemaker in the right ventricle
- Morbid obesity which may prevent the LivIQ device from obtaining telemetry communication within a range of 20 cm, in the physician's judgement
- Intolerance of dexamethasone acetate
- 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
- Allergy to the materials of the leadless pacemaker or the implant tools that are in contact with the human body
- Prior leadless pacemaker implant attempt
- 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
- 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.
- Planned ICD or CRT device implant
- Unstable angina pectoris or acute myocardial infarction within 30 days prior to enrollment
- Life expectancy of less than 12 months
- Unable to tolerate an urgent sternotomy
- 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
- Listed for or has received a heart transplantation or has a left ventricular assist device (LVAD)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotronik, Inc.lead
- Biotronik SE & Co. KGcollaborator
- Biotronik Japan, Inc.collaborator
- Biotronik Australia Pty Ltd.collaborator
Study Sites (23)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Samuel Asirvatham, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2025
First Posted
August 12, 2025
Study Start
March 16, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
July 30, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning no later than 12 months and ending no earlier than 3 years following initial publication of clinical study results.
- Access Criteria
- Researchers who provide a methodologically sound proposal for analysis that is not pre-planned or already approved with another researcher. Proposals must be approved by BIOTRONIK and Study Principal Investigator. Proposals should be directed to BIOTRONIK Clinical Studies (BIOTRONIK Inc., Attn: Clinical Studies, 6024 Jean Road, Lake Oswego, OR 97035; 1-800-547-0394). To gain access, data requesters will need to sign a data use/access agreement.
Applicable de-identified individual participant data will be made available to achieve aims in approved proposals, including but not limited to sub-analysis or meta-analysis.