Leadless PacemakerBIO-LivIQNCT07118358
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
A study testing LivIQ Leadless Pacemaker System in people with Leadless Pacemaker and Bradycardia, run by Biotronik, Inc. at 43 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leadless Pacemaker, Bradycardia, AV Block
- What is being tested?
- LivIQ Leadless Pacemaker System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 43 sitesin 8 countries
- Study dates
- 16 Mar 2026to Apr 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
- 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
- Unable to attend in-person planned or emergent study site visits (e.g., frequent or extended travel plans)
- 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:
- Willing and able to perform the requested procedures for the AVS assessments
- 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
Trial locations and contacts
43 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
43 sites in 8 countries
United States24 sites, 24 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Sutter Health
Burlingame, California, 94010
- Recruiting
Advocate/Atrium Health Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
- Recruiting
UVA Health University Medical Center
Charlottesville, Virginia, 22903
- Recruiting
UC San Diego Health
La Jolla, California, 92037
- Recruiting
MemorialCare Saddleback Medical
Laguna Hills, California, 92653
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
- Recruiting
South Denver Cardiology
Littleton, Colorado, 80120
- Recruiting
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
- Recruiting
NYU Heart Rhythm Center
New York, New York, 10016
- Recruiting
NY Presbyterian Weill Cornell Medicine
New York, New York, 10021
- Recruiting
Orlando Health Heart & Vascular Institute
Orlando, Florida, 32806
- Recruiting
Cardiology Consultants of Philadelphia
Paoli, Pennsylvania, 19301
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
- Recruiting
WakeMed
Raleigh, North Carolina, 27610
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
- Recruiting
Washington University
St Louis, Missouri, 63110
- Recruiting
Montefiore Medical Center - Moses Division
The Bronx, New York, 10467
- Recruiting
Cardiology Associates Medical Group
Ventura, California, 93003
- Recruiting
Wake Forest University Health
Winston-Salem, North Carolina, 27157
- Recruiting
WellSpan Health York Hospital
York, Pennsylvania, 17403
- Recruiting
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197
Belgium4 sites, 4 recruiting
- Recruiting
AZ Sint-Jan
Bruges, 8000
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
- Recruiting
UZ Leuven Gasthuisberg
Leuven, 3000
- Recruiting
CHR de la Citadelle - Liège
Liège, 4000
Australia3 sites, 3 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
- Recruiting
Victorian Heart Hospital
Clayton, Victoria, 3168
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
France3 sites, 3 recruiting
- Recruiting
Hôpital Gabriel Montpied, Clermont Ferrand
Clermont-Ferrand, BP69-63003
- Recruiting
Hôpital Europeén Georges Pompidou
Paris, 75908
- Recruiting
Hôpital Haut Lévêque (CHU)
Pessac, 33600
Germany3 sites, 3 recruiting
- Recruiting
Kerckhoff-Klinik GmbH
Bad Nauheim, Hesse, 61231
- Recruiting
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
- Recruiting
Heinrich-Heine Universität Düsseldorf
Düsseldorf, 40225
Netherlands3 sites, 3 recruiting
- Recruiting
OLVG
Amsterdam, 1090
- Recruiting
Research & Innovation Heart Centre St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
- Recruiting
HagaZiekenhuis van Den Haag - Leyweg
The Hague, 2545
Japan2 sites
- Active, not recruiting
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
- Active, not recruiting
National Cerebral and Cardiovascular Center Hospital
Suita, Osaka, 564-8565
Austria1 site, 1 recruiting
- Recruiting
Kepler Universitätsklinikum GmbH
Linz, 4021
About this study
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.
Read the 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.
- Conditions
- Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
- Being tested
- LivIQ Leadless Pacemaker System
- Keywords
- leadless pacemaker
- Medical subject headings
- Bradycardia, Atrioventricular Block, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LivIQ Leadless Pacemaker SystemDevice
Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.
| Study group | Role | What they receive |
|---|---|---|
| Non randomized arm | Other | Single Arm Receives: Device: LivIQ Leadless Pacemaker System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (10)
Improvement in SF-36 Role Physical Scale
Assess improvement in SF-36 role physical scale from baseline to the 6-month follow-up visit
Measured: Baseline and 6 months
Ventricular Capture Control Operation
Demonstrate the accuracy of LivIQ Ventricular Capture Control (VCC) operation at the 3-month follow-up visit.
Measured: 3 months
Rate Response Operation
Demonstrate adequate rate response operation of the LivIQ at the 3-month follow-up visit in a sub-set of patients (rate response sub-cohort).
Measured: 3 months
SADEs Related to the LivIQ System and/or Procedure
Confirm clinical safety based on freedom from SADEs related to the LivIQ system and/or procedure through 3 months, 6 months, and 12 months post-implant.
Measured: 3, 6, 12 months
Pacing Performance
Confirm adequate and stable pacing at the 6- and 12-month follow-up visits.
Measured: 6, 12 months
Pacing and Sensing Performance
Confirm adequate pacing and sensing at the 6- and 12-month follow-up visits.
Measured: 6, 12 months
Health-Related Quality of Life - EQ-5D-5L
Measure any changes in HRQOL according to the EQ-5D-5L scores from baseline to 3- and 6-month follow-up visits.
Measured: Baseline, 3, 6 months
Health-Related Quality of Life - SF-36
Measure any changes in HRQOL according to the mental/physical component summary scores of the SF-36 from baseline to 3- and 6-month follow-up visits
Measured: Baseline, 3, 6 months
Battery Longevity
Summarize the projected LivIQ battery longevity estimates at the 12-month visit.
Measured: 12 months
2-Year Survival Rate
Demonstrate that the 2-year survival following LivIQ implant in U.S. subjects exceeds a pre-specified performance goal
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start16 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leadless PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, prospective, single-arm, multi-center, international study
- Masking
- None (open label)
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotronik SE & Co. KG, Biotronik Japan, Inc., Biotronik Australia Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Samuel Asirvatham, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118358
- Sponsor's protocol ID
- BIO-LivIQ
- Acronym
- BIO-LivIQ
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.