BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
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.
• 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