RecruitingNot ApplicableNCT07118358

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

Sponsor

Biotronik, Inc.

Enrollment

325 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

Cardiac Rhythm Disorder Bradycardia AV Block Leadless Pacemaker

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called LivIQ Leadless Pacemaker System for people with av block, bradycardia, and other related conditions. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELivIQ Leadless Pacemaker System

Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.

Locations(23)

Sutter Health

Burlingame, California, United States

MemorialCare Saddleback Medical

Laguna Hills, California, United States

Trinity Health Ann Arbor Hospital

Ypsilanti, Michigan, United States

NY Presbyterian Weill Cornell Medicine

New York, New York, United States

Wake Forest University Health

Winston-Salem, North Carolina, United States

Cardiology Consultants of Philadelphia

Paoli, Pennsylvania, United States

UVA Health University Medical Center

Charlottesville, Virginia, United States

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Victorian Heart Hospital

Clayton, Victoria, Australia

AZ Sint-Jan

Bruges, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium

CHR de la Citadelle - Liège

Liège, Belgium

Hôpital Gabriel Montpied, Clermont Ferrand

Clermont-Ferrand, France

Hôpital Europeén Georges Pompidou

Paris, France

Hôpital Haut Lévêque (CHU)

Pessac, France

Kerckhoff-Klinik GmbH

Bad Nauheim, Hesse, Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Heinrich-Heine Universität Düsseldorf

Düsseldorf, Germany

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

National Cerebral and Cardiovascular Center Hospital

Suita, Osaka, Japan

Research & Innovation Heart Centre St. Antonius Ziekenhuis

Nieuwegein, Netherlands

HagaZiekenhuis van Den Haag - Leyweg

The Hague, Netherlands

View Full Details on ClinicalTrials.gov

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NCT07118358

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