BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
NCT07118358 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 325
Last updated 2026-04-06
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.
Conditions
- Leadless Pacemaker
- Bradycardia
- AV Block
- Cardiac Rhythm Disorder
Interventions
- DEVICE
-
LivIQ Leadless Pacemaker System
Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.
Sponsors & Collaborators
-
Biotronik SE & Co. KG
collaborator INDUSTRY -
Biotronik Japan, Inc.
collaborator INDUSTRY -
Biotronik Australia Pty Ltd.
collaborator INDUSTRY -
Biotronik, Inc.
lead INDUSTRY
Principal Investigators
-
Samuel Asirvatham, MD · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-16
- Primary Completion
- 2027-03-31
- Completion
- 2028-04-30
- FDA Device
- Yes
Countries
- Japan
Study Locations
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