BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
Start Date
3/16/2026
Completion Date
4/1/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
LivIQ Leadless Pacemaker System
Conditions
Locations
Sutter Health
Burlingame, California 94010
United States
MemorialCare Saddleback Medical
Laguna Hills, California 92653
United States
Trinity Health Ann Arbor Hospital
Ypsilanti, Michigan 48197
United States
NY Presbyterian Weill Cornell Medicine
New York, New York 10021
United States
Wake Forest University Health
Winston-Salem, North Carolina 27157
United States
Cardiology Consultants of Philadelphia
Paoli, Pennsylvania 19301
United States
UVA Health University Medical Center
Charlottesville, Virginia 22903
United States
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
Australia
Victorian Heart Hospital
Clayton, Victoria 3168
Australia
AZ Sint-Jan
Bruges, 8000
Belgium
Jessa Ziekenhuis
Hasselt, 3500
Belgium
UZ Leuven Gasthuisberg
Leuven, 3000
Belgium
CHR de la Citadelle - Liège
Liège, 4000
Belgium
Hôpital Gabriel Montpied, Clermont Ferrand
Clermont-Ferrand, BP69-63003
France
Hôpital Europeén Georges Pompidou
Paris, 75908
France
Hôpital Haut Lévêque (CHU)
Pessac, 33600
France
Kerckhoff-Klinik GmbH
Bad Nauheim, Hesse 61231
Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia 32545
Germany
Heinrich-Heine Universität Düsseldorf
Düsseldorf, 40225
Germany
Kokura Memorial Hospital
Kitakyushu, Fukuoka 802-8555
Japan
National Cerebral and Cardiovascular Center Hospital
Suita, Osaka 564-8565
Japan
Research & Innovation Heart Centre St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
Netherlands
HagaZiekenhuis van Den Haag - Leyweg
The Hague, 2545
Netherlands