AV Block, Bradycardia, Cardiac Rhythm Disorder, Leadless Pacemaker
Conditions
Keywords
leadless pacemaker
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.
Detailed description
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.
Interventions
DEVICELivIQ Leadless Pacemaker System
Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.
Sponsors
Biotronik, Inc.
Biotronik SE & Co. KG
Biotronik Japan, Inc.
Biotronik Australia Pty Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, prospective, single-arm, multi-center, international study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Serious Adverse Device Effects | 3 months | Demonstrate that the freedom from SADEs related to the LivIQ system and/or procedure through 3-month follow-up exceeds the performance goal. |
| Percentage of Subjects with Adequate Pacing | 3 months | Demonstrate that the percentage of subjects with adequate and stable pacing at the 3-month follow-up visit exceeds the performance goal. |
| Percentage of Subjects with Adequate Pacing and Sensing | 3 months | Demonstrate that the percentage of subjects with adequate pacing and sensing at the 3-month follow-up visit exceeds the performance goal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in SF-36 Role Physical Scale | Baseline and 6 months | Assess improvement in SF-36 role physical scale from baseline to the 6-month follow-up visit |
| Ventricular Capture Control Operation | 3 months | Demonstrate the accuracy of LivIQ Ventricular Capture Control (VCC) operation at the 3-month follow-up visit. |
| Rate Response Operation | 3 months | 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). |
| SADEs Related to the LivIQ System and/or Procedure | 3, 6, 12 months | 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. |
| Pacing Performance | 6, 12 months | Confirm adequate and stable pacing at the 6- and 12-month follow-up visits. |
| Pacing and Sensing Performance | 6, 12 months | Confirm adequate pacing and sensing at the 6- and 12-month follow-up visits. |
| Health-Related Quality of Life - EQ-5D-5L | Baseline, 3, 6 months | Measure any changes in HRQOL according to the EQ-5D-5L scores from baseline to 3- and 6-month follow-up visits. |
| Health-Related Quality of Life - SF-36 | Baseline, 3, 6 months | 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 |
| Battery Longevity | 12 months | Summarize the projected LivIQ battery longevity estimates at the 12-month visit. |
| 2-Year Survival Rate | 24 months | Demonstrate that the 2-year survival following LivIQ implant in U.S. subjects exceeds a pre-specified performance goal |
Countries
Australia, Austria, Belgium, France, Germany, Japan, Netherlands, United States
Contacts
CONTACTJennifer Alkire Project Manager
CONTACTAndreas Peth Clinical Project Manager
STUDY_CHAIRSamuel Asirvatham, MD
Mayo Clinic
Outcome results
None listed