Clinical Trial

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

Study acronym: BIO-LivIQ
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
notable Trial sites expanded: 23 -> 28 locations 2026-08-14
notable Trial sites expanded: 20 -> 23 locations 2026-07-31
notable Trial sites expanded: 13 -> 20 locations 2026-07-15
notable Trial sites expanded: 2 -> 13 locations 2026-06-19
critical Recruitment opened 2026-04-07
Trial Details
NCT Number NCT07118358
Lead Sponsor Biotronik, Inc.
Collaborators: Biotronik SE & Co. KG, Biotronik Japan, Inc., Biotronik Australia Pty Ltd.
Conditions Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
Enrollment 325 participants
Start Date 2026-03-16
Primary Completion 2027-03 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-13