Health Trials

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 group

Locations

13
Australia
Princess Alexandra Hospital4102, WoolloongabbaQueensland, Australia
Victorian Heart Hospital3168, ClaytonVictoria, Australia
Belgium
AZ Sint-Jan8000, Bruges Belgium
Jessa Ziekenhuis3500, Hasselt Belgium

Sponsors and collaborators

Biotronik, Inc.

Lead sponsor

Biotronik SE & Co. KG

Collaborator

Biotronik Japan, Inc.

Collaborator

Biotronik Australia Pty Ltd.

Collaborator

Source ClinicalTrials.gov