BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

Study acronym: BIO-LivIQ
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Trial sites expanded: 39 → 43 locations
  2. Trial sites expanded: 36 → 39 locations
  3. Trial sites expanded: 28 → 36 locations
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 2 of 10 entries
    • Collaborators: details revised at 1 of 3 entries
  4. Trial sites expanded: 23 → 28 locationsv7
  5. Trial sites expanded: 20 → 23 locationsv6
  6. Trial sites expanded: 13 → 20 locationsv5
  7. Trial sites expanded: 2 → 13 locationsv4
  8. Recruitment opened
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 2026 to Mar 16, 2026
    v3
  9. Lead sponsor: [Redacted] to Biotronik, Inc.v2 Show 6 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Mar 2027
    • Study completion date: Apr 2028
    • Start date: Mar 2026
    • Collaborators expanded, about 12 words
    • Study title shortened, about 5 words
  10. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07118358
Lead Sponsor Biotronik, Inc.
Collaborators: Biotronik SE & Co. KG, Biotronik Japan, Inc., Biotronik Australia Pty Ltd.
Conditions
(from sponsor)		 Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
Related terms Arrhythmias, Cardiac, Atrioventricular Block, Bradycardia
Enrollment 325 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov