BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiotronik, Inc.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
LivIQ Leadless Pacemaker System
DevicePatients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.
Treatment groups
325 Participants
are divided into 1 treatment groupGroup A: Non randomized armOther 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from Serious Adverse Device Effects
Demonstrate that the freedom from SADEs related to the LivIQ system and/or procedure through 3-month follow-up exceeds the performance goal.
Time frame
3 months2
Percentage of Subjects with Adequate Pacing
Demonstrate that the percentage of subjects with adequate and stable pacing at the 3-month follow-up visit exceeds the performance goal.
Time frame
3 months3
Percentage of Subjects with Adequate Pacing and Sensing
Demonstrate that the percentage of subjects with adequate pacing and sensing at the 3-month follow-up visit exceeds the performance goal.
Time frame
3 monthsSecondary outcomes
1
Improvement in SF-36 Role Physical Scale
Assess improvement in SF-36 role physical scale from baseline to the 6-month follow-up visit
Time frame
Baseline and 6 months2
Ventricular Capture Control Operation
Demonstrate the accuracy of LivIQ Ventricular Capture Control (VCC) operation at the 3-month follow-up visit.
Time frame
3 months3
Rate Response Operation
Demonstrate adequate rate response operation of the LivIQ at the 3-month follow-up visit in a sub-set of patients (rate response sub-cohort).
Time frame
3 months4
SADEs Related to the LivIQ System and/or Procedure
Confirm clinical safety based on freedom from SADEs related to the LivIQ system and/or procedure through 3 months, 6 months, and 12 months post-implant.
Time frame
3, 6, 12 monthsSponsors and contacts
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Biotronik, Inc.
Lead sponsor
Biotronik SE & Co. KG
Collaborator
Biotronik Japan, Inc.
Collaborator
Biotronik Australia Pty Ltd.
Collaborator
Source ClinicalTrials.gov