BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiotronik, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- LivIQ Leadless Pacemaker System
Treatment groups
325 Participants
are divided into 1 treatment groupSponsors and collaborators
Biotronik, Inc.
Lead sponsor
Biotronik SE & Co. KG
Collaborator
Biotronik Japan, Inc.
Collaborator
Biotronik Australia Pty Ltd.
Collaborator
Source ClinicalTrials.gov