None listed
Conditions
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.
Interventions
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
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.
Sponsors
BIOTRONIK Australia Pty. Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed