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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
325
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sutter Health
Burlingame, California, United States
RECRUITINGMemorialCare Saddleback Medical
Laguna Hills, California, United States
RECRUITINGCardiology Associates Medical Group
Ventura, California, United States
RECRUITINGSouth Denver Cardiology
Littleton, Colorado, United States
RECRUITINGOrlando Health Heart & Vascular Institute
Orlando, Florida, United States
RECRUITINGSarasota Memorial Health Care System
Sarasota, Florida, United States
RECRUITINGBaptist Health Lexington
Lexington, Kentucky, United States
RECRUITINGTrinity Health Michigan Heart
Ypsilanti, Michigan, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGNYU Heart Rhythm Center
New York, New York, United States
RECRUITING...and 26 more locations
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