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

Inclusion Criteria7

Class I or Class II indication for ventricular pacing (VVI/VDD) according to applicable guidelines
Age is greater than or equal to 18 years at time of consent
Able to understand the nature of the study and provide written informed consent
Able and willing to complete all study requirements, including completion of all planned in-office study visits, for the expected duration of follow-up
After consenting to the main study, patients potentially eligible for the AVS Sub-Study must meet these additional criteria:
Willing and able to perform the requested procedures for the AVS assessments
Current or history of AV block Note: This includes patients with any degree or type of AV block, irrespective of related symptoms and relevance of the AV block for the underlying pacemaker indication

Exclusion Criteria20

AV block with a ventricular escape rhythm ≤ 30 bpm at time of consent Note: Restriction removed after early safety phase objectives are met
Femoral venous anatomy that is unable to accommodate the introducer or the cardiac anatomy does not allow a leadless pacemaker in the right ventricle
Morbid obesity which may prevent the LivIQ device from obtaining telemetry communication within a range of 20 cm, in the physician's judgement
Intolerance of dexamethasone acetate
Other implanted devices that, in the judgement of the implanting physician, could interfere (mechanically or electrically) with the leadless pacemaker or with the implant procedure
Allergy to the materials of the leadless pacemaker or the implant tools that are in contact with the human body
Prior leadless pacemaker implant attempt
Existing transvenous or leadless pacemaker, transvenous or subcutaneous ICD, or CRT device or previous extraction in which transvenous leads (full or partial) were left in the heart Note: Exception given to use temporary transvenous pacemakers
CIED device extraction within the previous 72 hours or signs of active infection after CIED extraction Note: Patients with extraction due to potential systemic infection must have a blood culture. A blood culture is considered negative if there is no growth within 72 hours prior to the LivIQ implant.
Planned ICD or CRT device implant
Unstable angina pectoris or acute myocardial infarction within 30 days prior to enrollment
Life expectancy of less than 12 months
Unable to tolerate an urgent sternotomy
Planned right-sided heart intervention within 30 days after implant Note: Exception given to AV nodal ablations when performed by an implanting investigator once early safety phase objectives are met
Listed for or has received a heart transplantation or has a left ventricular assist device (LVAD)
Participation or plan to participate in any other potentially confounding investigational drug or device trial, or any other clinical trial that may interfere with this study's treatment or protocol during the duration of the study Note: Co-enrollment in concurrent trials is only allowed when documented prior approval is obtained from BIOTRONIK
Unable to attend in-person planned or emergent study site visits (e.g., frequent or extended travel plans)
Pregnant or plan to become pregnant during the duration of the study
After consenting to the main study, patients potentially eligible for the AVS Sub-Study must not meet the following criterion:
\. Permanent AF