An interventional study of LivIQ Leadless Pacemaker System in Leadless Pacemaker, Bradycardia and AV Block, sponsored by Biotronik, Inc.. Recruiting at 43 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Biotronik, Inc. · Not applicable, Interventional, and Treatment
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.
BIO-LivIQ is designed as an open-label, prospective, single-arm, multi-center, international study. A total of 325 subjects will be enrolled across up to 60 centers from the U.S., Europe, and Asia Pacific.
Within the study, identified patients will be enrolled after a medical record review to determine if all inclusion criteria and no exclusion criteria are met. Once informed consent is obtained, subjects will be examined on-site at enrollment, implant, pre-hospital discharge, 1 month, 3 months, 6 months and 12 months , with continued in-person follow-up every 6 months until regional market approval. After U.S. market approval, a required remote 24-month visit will be conducted to assess vital status.
The performance of VDD pacing will be evaluated in the AVS sub-study. Once informed consent is obtained for this sub-study, AVS Holter data will be collected at 1-month and 6-month follow-ups.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 325 is above the median of 100 across 187 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →Biotronik, Inc. is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
AVS Sub-Study Inclusion Criteria:
After consenting to the main study, patients potentially eligible for the AVS Sub-Study must meet these additional criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single Arm
Device: LivIQ Leadless Pacemaker System
Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.
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 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.
Time frame: 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.
Time frame: 3 months
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 months
Ventricular Capture Control Operation
Demonstrate the accuracy of LivIQ Ventricular Capture Control (VCC) operation at the 3-month follow-up visit.
Time frame: 3 months
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 months
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 months
Pacing Performance
Confirm adequate and stable pacing at the 6- and 12-month follow-up visits.
Time frame: 6, 12 months
Pacing and Sensing Performance
Confirm adequate pacing and sensing at the 6- and 12-month follow-up visits.
Time frame: 6, 12 months
Health-Related Quality of Life - EQ-5D-5L
Measure any changes in HRQOL according to the EQ-5D-5L scores from baseline to 3- and 6-month follow-up visits.
Time frame: Baseline, 3, 6 months
Health-Related Quality of Life - SF-36
Measure any changes in HRQOL according to the mental/physical component summary scores of the SF-36 from baseline to 3- and 6-month follow-up visits
Time frame: Baseline, 3, 6 months
Battery Longevity
Summarize the projected LivIQ battery longevity estimates at the 12-month visit.
Time frame: 12 months
2-Year Survival Rate
Demonstrate that the 2-year survival following LivIQ implant in U.S. subjects exceeds a pre-specified performance goal
Time frame: 24 months
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — Applicable de-identified individual participant data will be made available to achieve aims in approved proposals, including but not limited to sub-analysis or meta-analysis.
Supporting information: Study protocol, Statistical analysis plan
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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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