LivIQ leadless pacemaker system for ventricular pacing

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

This trial will test the LivIQ leadless pacemaker in adults who need ventricular pacing (VVI or VDD) to see if it is safe and maintains appropriate heart rhythm and AV timing.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 325 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biotronik, Inc. (industry)
• Locations: 2 sites (Kitakyushu, Fukuoka and 1 other locations)
• Trial ID: NCT07118358 on ClinicalTrials.gov

What this trial studies

This is an open‑label, prospective, single‑arm international study enrolling 325 subjects across up to 60 centers in the U.S., Europe, and Asia‑Pacific. Eligible adults with a Class I or II indication for ventricular pacing are enrolled after medical‑record review and informed consent and receive the LivIQ leadless pacemaker. Participants are seen at implant, pre‑discharge, 1, 3, 6, and 12 months and then every 6 months until regional market approval, with a required remote 24‑month check after U.S. approval. An integrated atrioventricular synchrony (AVS) sub‑study collects Holter data at 1 and 6 months to test VDD pacing performance.

Who should consider this trial

Good fit: Adults (≥18 years) with a Class I or II guideline indication for ventricular pacing (VVI or VDD) who can provide informed consent and complete scheduled follow‑up are ideal candidates.

Not a fit: Patients with femoral venous or cardiac anatomy that precludes implantation, morbid obesity preventing required telemetry range, intolerance to dexamethasone acetate, or certain severe AV block with very low escape rhythm may not receive benefit.

Why it matters

Potential benefit: If successful, the LivIQ system could offer a leadless ventricular pacing option that preserves AV synchrony and reduces complications related to transvenous leads.

How similar studies have performed: Prior leadless pacemakers have demonstrated good safety and pacing performance, and AV‑synchrony‑enabled leadless devices have shown promising but still emerging results.

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 all study requirements, including completion of all planned in-office study visits, for the expected duration of follow-up

Exclusion criteria:

1. AV block with a ventricular escape rhythm ≤ 30 bpm at time of consent Note: Restriction removed after early safety phase objectives are met
2. Femoral venous anatomy that is unable to accommodate the introducer or the cardiac anatomy does not allow a leadless pacemaker in the right ventricle
3. Morbid obesity which may prevent the LivIQ device from obtaining telemetry communication within a range of 20 cm, in the physician's judgement
4. Intolerance of dexamethasone acetate
5. 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
6. Allergy to the materials of the leadless pacemaker or the implant tools that are in contact with the human body
7. Prior leadless pacemaker implant attempt
8. 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
9. 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.
10. Planned ICD or CRT device implant
11. Unstable angina pectoris or acute myocardial infarction within 30 days prior to enrollment
12. Life expectancy of less than 12 months
13. Unable to tolerate an urgent sternotomy
14. 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
15. Listed for or has received a heart transplantation or has a left ventricular assist device (LVAD)
16. 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
17. Unable to attend in-person planned or emergent study site visits (e.g., frequent or extended travel plans)
18. 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:

1. Willing and able to perform the requested procedures for the AVS assessments
2. 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 this trial is running

Kitakyushu, Fukuoka and 1 other locations

• Kokura Memorial Hospita — Kitakyushu, Fukuoka, Japan (RECRUITING)
• National Cerebral and Cardiovascular Center Hospital — Suita, Osaka, Japan (RECRUITING)

Study contacts

• Study coordinator: Jennifer Alkire Project Manager

Conditions: Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder, leadless pacemaker