BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System (NCT07118358) | Clinical Trial Compass
RecruitingNot Applicable
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
Japan325 participantsStarted 2026-03-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Freedom from Serious Adverse Device Effects
Timeframe: 3 months
2
Percentage of Subjects with Adequate Pacing
Timeframe: 3 months
3
Percentage of Subjects with Adequate Pacing and Sensing
. 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