Trial Review

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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
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
Secondary ID [1] 314500 0
BA122
Universal Trial Number (UTN)
Trial acronym
BIO|CONCEPT.LivIQ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bradycardia 337564 0
Condition category
Condition code
Cardiovascular 333914 333914 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 331123 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341558 0
Serious adverse device effects
Timepoint [1] 341558 0
1-month after implantation
Secondary outcome [1] 447922 0
Adequate sensing
Timepoint [1] 447922 0
1-month after implantation
Secondary outcome [2] 447925 0
Pauses
Timepoint [2] 447925 0
1-month after implantation
Secondary outcome [3] 448205 0
Adequate pacing
Timepoint [3] 448205 0
1-month after implantation

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/09/2025
Actual
Date of last participant enrolment
Anticipated
17/10/2025
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 319039 0
Commercial sector/Industry
Name [1] 319039 0
BIOTRONIK Australia Pty. Ltd.
Country [1] 319039 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BIOTRONIK Australia Pty. Ltd.
Address
Country
Australia
Secondary sponsor category [1] 321506 0
None
Name [1] 321506 0
Address [1] 321506 0
Country [1] 321506 0
Other collaborator category [1] 283530 0
Commercial sector/Industry
Name [1] 283530 0
BIOTRONIK SE & Co.KG
Address [1] 283530 0
Country [1] 283530 0
Germany

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317647 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317647 0
Ethics committee country [1] 317647 0
Australia
Date submitted for ethics approval [1] 317647 0
04/06/2025
Approval date [1] 317647 0
Ethics approval number [1] 317647 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141686 0
A/Prof Paul Gould
Address 141686 0
Princess Alexandra Hospital 199 Ipswich Road QLD 4102 Woolloongabba
Country 141686 0
Australia
Phone 141686 0
+610731766375
Fax 141686 0
Email 141686 0
[email protected]
Contact person for public queries
Name 141687 0
Falko Thiele
Address 141687 0
BIOTRONIK Australia Pty Ltd, Level 4, Building 2, 20 Bridge St Pymble NSW 2073
Country 141687 0
Australia
Phone 141687 0
+61294973719
Fax 141687 0
Email 141687 0
[email protected]
Contact person for scientific queries
Name 141688 0
Dr. Silke Krüger
Address 141688 0
BIOTRONIK SE & Co.KG, Woermannkehre 1, 12359 Berlin
Country 141688 0
Germany
Phone 141688 0
+4915168902786
Fax 141688 0
Email 141688 0
[email protected]

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.