BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

Recruiting N/A Interventional Study
Leadless Pacemaker Bradycardia AV Block Cardiac Rhythm Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
325 (estimated)
Sponsor
Biotronik, Inc. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion criteria: 1. Class I or Class II indication for ventricular pacing (VVI/VDD) according to applicable guidelines 2. Age is greater than or equal to 18 years at time of consent 3. Able to understand the nature of the study and provide written informed consent 4. Able and willing to complete…
Contacts

Jennifer Alkire Project Manager

800-547-0394

US-BIO-LivIQ@biotronik.com

CONTACT

Andreas Peth Clinical Project Manager

+49 30 68905 1288

BIO-LivIQ@biotronik.com

CONTACT