BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

NCT07118358 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: BIO-LivIQ
• Study Type: interventional
• Target: 325
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Leadless Pacemaker; Bradycardia; AV Block; Cardiac Rhythm Disorder

Keywords

leadless pacemaker

Outcome Measures

Primary Outcomes (3)

• 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.

  3 months

• 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.

  3 months

• 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.

  3 months

Secondary Outcomes (10)

• Improvement in SF-36 Role Physical Scale

  Baseline and 6 months

• Ventricular Capture Control Operation

  3 months

• Rate Response Operation

  3 months

• SADEs Related to the LivIQ System and/or Procedure

  3, 6, 12 months

• Pacing Performance

  6, 12 months

Study Arms (1)

Non randomized arm

OTHER

Single Arm

Device: LivIQ Leadless Pacemaker System

Interventions

LivIQ Leadless Pacemaker System DEVICE

Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.

Non randomized arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Biotronik, Inc.: lead
• Biotronik SE & Co. KG: collaborator
• Biotronik Japan, Inc.: collaborator
• Biotronik Australia Pty Ltd.: collaborator

MeSH Terms

Conditions

Bradycardia; Atrioventricular Block; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease

Study Officials

• Samuel Asirvatham, MD

  Mayo Clinic

  STUDY CHAIR

Central Study Contacts

Jennifer Alkire Project Manager

CONTACT

800-547-0394; US-BIO-LivIQ@biotronik.com

Andreas Peth Clinical Project Manager

CONTACT

+49 30 68905 1288; BIO-LivIQ@biotronik.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, prospective, single-arm, multi-center, international study

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 12, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning no later than 12 months and ending no earlier than 3 years following initial publication of clinical study results.
• Access Criteria: Researchers who provide a methodologically sound proposal for analysis that is not pre-planned or already approved with another researcher. Proposals must be approved by BIOTRONIK and Study Principal Investigator. Proposals should be directed to BIOTRONIK Clinical Studies (BIOTRONIK Inc., Attn: Clinical Studies, 6024 Jean Road, Lake Oswego, OR 97035; 1-800-547-0394). To gain access, data requesters will need to sign a data use/access agreement.