NCT07118358

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 325 (estimated)
• Sponsor: Biotronik, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

BIO-LivIQ is designed as an open-label, prospective, single-arm, multi-center, international study. A total of 325 subjects will be enrolled across up to 60 centers from the U.S., Europe, and Asia Pacific. Within the study, identified patients will be enrolled after a medical record review to determine if all inclusion criteria and no exclusion criteria are met. Once informed consent is obtained, subjects will be examined on-site at enrollment, implant, pre-hospital discharge, 1 month, 3 months, 6 months and 12 months , with continued in-person follow-up every 6 months until regional market approval. After U.S. market approval, a required remote 24-month visit will be conducted to assess vital status. The performance of VDD pacing will be evaluated in the AVS sub-study. Once informed consent is obtained for this sub-study, AVS Holter data will be collected at 1-month and 6-month follow-ups.

Conditions

• Leadless Pacemaker
• Bradycardia
• AV Block
• Cardiac Rhythm Disorder

Interventions

Type	Name	Description
DEVICE	LivIQ Leadless Pacemaker System	Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.

Timeline

• Start date: 2026-03-16
• Primary completion: 2027-03-01
• Completion: 2028-04-01
• First posted: 2025-08-12
• Last updated: 2026-04-06

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated device study