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Trial registered on ANZCTR
Registration number
ACTRN12625000588493p
Ethics application status
Submitted, not yet approved
Date submitted
20/05/2025
Date registered
6/06/2025
Date last updated
12/06/2025
Date data sharing statement initially provided
6/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Clinical study with BIOTRONIK’s leadless pacemaker system used for the first time in patients needing ventricular pacing
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Scientific title
First-in-Human study for the LivIQ leadless pacemaker system to determine preliminary safety and product performance of the device in patients with a class I or II indication for ventricular pacing
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Secondary ID [1]
314500
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BA122
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Universal Trial Number (UTN)
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Trial acronym
BIO|CONCEPT.LivIQ
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bradycardia
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Condition category
Condition code
Cardiovascular
333914
333914
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Pre-market, first-in-human, explorative study:
Implantation of a novel leadless pacemaker in patients with class I or II indication for ventricular pacing (VVI/VDD) according to applicable guidelines.
The LivIQ VR-T DX is an intracardiac single chamber leadless pacemaker that is designed to be an entirely self-contained device for implant into the right ventricle.
The leadless pacemaker is intended to administer rate-adaptive, ventricular pacing. The leadless pacemaker has the ability, first, to sense the intrinsic heart rhythm/rate and, second, to provide pacing by electrical pulses of low energy when necessary to ensure a stable heart rate or to support the intrinsic heart rate when needed.
The LivIQ leadless pacemaker has to be implanted by an experienced cardiologist according to the required LivIQ training program and specific information pertaining to procedures provided in the respective technical manual. The implantation duration is expected to take 1 to 2 hours on average. After implantation, the device remains implanted until exchange is indicated due to end of battery life time, which is estimated with up to 10 years.
Patients will undergo a 24h Holter measurement 1 month after implantation as well as an activity assessent during the 1-month in-office visit. During the in-office assesment patients will be asked to take different poitions (lying, sitting, standing) as well as some activities (walkig, fast walking, treadmill) according to their medical condition and at discretion of the treating investigator. The expected duration of the follow-up is 40 to 60 minutes.
Following the 1-month follow-up patients will be continued to be observed for adverse events until the device received TGA approval and market release in Australia to fulfill reporting requirements while device is not freely available on the market. The safety surveillance period is not related to the primary study outcomes.
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Intervention code [1]
331123
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Serious adverse device effects
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Assessment method [1]
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Total number of SADEs is assessed for this endpoints. Adverse Event reporting is required during the course of the study following ISO14155 reporting requirements. The definition of SADEs as provided by ISO14155 is followed to identify events that are contributing to the endpoint.
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Timepoint [1]
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1-month after implantation
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Secondary outcome [1]
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Adequate sensing
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Assessment method [1]
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Total number of patients with adequate sensing. Adequate sensing is assessed based on sensing values measured by the pacemaker.
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Timepoint [1]
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1-month after implantation
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Secondary outcome [2]
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Pauses
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Assessment method [2]
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Total number of patients presented with pauses during a 24h Holter measurement
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Timepoint [2]
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1-month after implantation
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Secondary outcome [3]
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Adequate pacing
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Assessment method [3]
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Total number of patients with adequate pacing. Adequate pacing is assessed based on sensing values measured by the pacemaker.
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Timepoint [3]
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1-month after implantation
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Eligibility
Key inclusion criteria
1. Class I or II indication for ventricular pacing (VVI/VDD) according to applicable guidelines
2. Age 18 years or older
3. Able to understand the nature of the study and provide written informed consent
4. Able and willing to complete all in-person study requirements, including completion of all routine in-office study visits, for the expected duration of follow-up
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. AV block with a ventricular escape rhythm equal or lower than 30 bpm
2. Contraindication(s) in the LivIQ implant technical manual
3. Prior leadless pacemaker implant attempt
4. 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
5. CIED device extracted within the previous 72 hours or patient has signs of active infection after CIED extraction
6. Planned ICD or CRT device implant
7. Unstable angina pectoris or acute myocardial infarction within 30 days prior to enrollment
8. Life expectancy of less than 12 months
9. Unable to tolerate an urgent sternotomy
10. Planned right-sided heart intervention within 30 days after implant
11. Listed for heart transplantation or has a left ventricular assist device (LVAD)
12. Participation in another interventional clinical investigation
13. Pregnant or planning to become pregnant during the duration of the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
17/09/2025
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Actual
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Date of last participant enrolment
Anticipated
17/10/2025
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Actual
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Date of last data collection
Anticipated
30/06/2029
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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BIOTRONIK Australia Pty. Ltd.
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
BIOTRONIK Australia Pty. Ltd.
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
321506
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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BIOTRONIK SE & Co.KG
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Address [1]
283530
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Country [1]
283530
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Germany
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
317647
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Metro South Human Research Ethics Committee
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Ethics committee address [1]
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https://www.metrosouth.health.qld.gov.au/research/research-ethics-and-governance/human-research-ethics-committee
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Ethics committee country [1]
317647
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Australia
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Date submitted for ethics approval [1]
317647
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04/06/2025
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Approval date [1]
317647
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Ethics approval number [1]
317647
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Summary
Brief summary
The purpose of this study is to gain first information on the safety and performance of the LivIQ leadless pacemaker system and to inform the preparation of procedures, workflows, and optimized device training for a subsequent international pivotal study investigating the LivIQ system. Its objective is to determine preliminary safety and product performance of LivIQ and understand the implantation experience with LivIQ from implanters’ perspective.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Paul Gould
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Address
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Princess Alexandra Hospital 199 Ipswich Road QLD 4102 Woolloongabba
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Country
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Australia
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Phone
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+610731766375
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Falko Thiele
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Address
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BIOTRONIK Australia Pty Ltd, Level 4, Building 2, 20 Bridge St Pymble NSW 2073
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Country
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Australia
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Phone
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+61294973719
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr. Silke Krüger
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Address
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BIOTRONIK SE & Co.KG, Woermannkehre 1, 12359 Berlin
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Country
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Germany
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Phone
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+4915168902786
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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