NCT07118358 · Biotronik, Inc.
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
(BIO-LivIQ)
What this study is about
The objective of this experimental 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.
View original scientific description
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.
Interventions
DEVICE
LivIQ Leadless Pacemaker System
Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.
Primary outcome measures
Freedom from Serious Adverse Device Effects
Time frame: 3 months
Demonstrate that the freedom from SADEs related to the LivIQ system and/or procedure through 3-month follow-up exceeds the performance goal.
Percentage of Subjects with Adequate Pacing
Time frame: 3 months
Demonstrate that the percentage of subjects with adequate and stable pacing at the 3-month follow-up visit exceeds the performance goal.
Percentage of Subjects with Adequate Pacing and Sensing
Time frame: 3 months
Demonstrate that the percentage of subjects with adequate pacing and sensing at the 3-month follow-up visit exceeds the performance goal.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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 AVS Sub-Study Inclusion Criteria: 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 AVS Sub-Study Exclusion Criteria: After consenting to the main study, patients potentially eligible for the AVS Sub-Study must not meet the following criterion: 1\. Permanent AF
Where
- Burlingame, California
- Laguna Hills, California
- Ypsilanti, Michigan
- New York, New York
- Winston-Salem, North Carolina
- Paoli, Pennsylvania
- Charlottesville, Virginia
Collaborators
Biotronik SE & Co. KG, Biotronik Japan, Inc., Biotronik Australia Pty Ltd.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 30, 2026 · Source of record for eligibility and locations