LivIQ Leadless Pacemaker System: Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 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
Primary outcome measure(s)
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.
Trial sites (39)
Facility
City
Region
Status
Sutter Health
Burlingame
California
Recruiting
UC San Diego Health
La Jolla
California
Recruiting
MemorialCare Saddleback Medical
Laguna Hills
California
Recruiting
Cardiology Associates Medical Group
Ventura
California
Recruiting
South Denver Cardiology
Littleton
Colorado
Recruiting
Orlando Health Heart & Vascular Institute
Orlando
Florida
Recruiting
Sarasota Memorial Health Care System
Sarasota
Florida
Recruiting
Baptist Health Lexington
Lexington
Kentucky
Recruiting
Trinity Health Michigan Heart
Ypsilanti
Michigan
Recruiting
Mayo Clinic
Rochester
Minnesota
Recruiting
Washington University
St Louis
Missouri
Recruiting
NYU Heart Rhythm Center
New York
New York
Recruiting
NY Presbyterian Weill Cornell Medicine
New York
New York
Recruiting
Advocate/Atrium Health Sanger Heart and Vascular Institute
Charlotte
North Carolina
Recruiting
WakeMed
Raleigh
North Carolina
Recruiting
Wake Forest University Health
Winston-Salem
North Carolina
Recruiting
Cardiology Consultants of Philadelphia
Paoli
Pennsylvania
Recruiting
Penn Presbyterian Medical Center
Philadelphia
Pennsylvania
Recruiting
UVA Health University Medical Center
Charlottesville
Virginia
Recruiting
Aurora St. Luke's Medical Center
Milwaukee
Wisconsin
Recruiting
Princess Alexandra Hospital
Woolloongabba
Queensland
Recruiting
Royal Adelaide Hospital
Adelaide
South Australia
Recruiting
Victorian Heart Hospital
Clayton
Victoria
Recruiting
Kepler Universitätsklinikum GmbH
Linz
Austria
Recruiting
AZ Sint-Jan
Bruges
Belgium
Recruiting
Jessa Ziekenhuis
Hasselt
Belgium
Recruiting
UZ Leuven Gasthuisberg
Leuven
Belgium
Recruiting
CHR de la Citadelle - Liège
Liège
Belgium
Recruiting
Hôpital Gabriel Montpied, Clermont Ferrand
Clermont-Ferrand
France
Recruiting
Hôpital Europeén Georges Pompidou
Paris
France
Recruiting
Hôpital Haut Lévêque (CHU)
Pessac
France
Recruiting
Kerckhoff-Klinik GmbH
Bad Nauheim
Hesse
Recruiting
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
North Rhine-Westphalia
Recruiting
Heinrich-Heine Universität Düsseldorf
Düsseldorf
Germany
Recruiting
Kokura Memorial Hospital
Kitakyushu
Fukuoka
Active Not Recruiting
National Cerebral and Cardiovascular Center Hospital
Suita
Osaka
Active Not Recruiting
OLVG
Amsterdam
Netherlands
Recruiting
Research & Innovation Heart Centre St. Antonius Ziekenhuis
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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