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New treatment option for Leadless Pacemaker
Official title BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
ClinicalTrials.gov ID: NCT07118358
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Class I or Class II indication for ventricular pacing (VVI/VDD) according to applicable guidelines
- Age is greater than or equal to 18 years at time of consent
- Able to understand the nature of the study and provide written informed consent
- Able and willing to complete all study requirements, including completion of all planned in-office study visits, for the expected duration of...
You likely can't join if
- AV block with a ventricular escape rhythm ≤ 30 bpm at time of consent Note: Restriction removed after early safety phase objectives are met
- Femoral venous anatomy that is unable to accommodate the introducer or the cardiac anatomy does not allow a leadless pacemaker in the right ventricle
- Morbid obesity which may prevent the LivIQ device from obtaining telemetry communication within a range of 20 cm, in the physician's judgement
- Intolerance of dexamethasone acetate
- Other implanted devices that, in the judgement of the implanting physician, could interfere (mechanically or electrically) with the leadless...
- Allergy to the materials of the leadless pacemaker or the implant tools that are in contact with the human body
See the full eligibility criteria
- Class I or Class II indication for ventricular pacing (VVI/VDD) according to applicable guidelines
- Age is greater than or equal to 18 years at time of consent
- Able to understand the nature of the study and provide written informed consent
- Able and willing to complete all study requirements, including completion of all planned in-office study visits, for the expected duration of follow-up
- AV block with a ventricular escape rhythm ≤ 30 bpm at time of consent Note: Restriction removed after early safety phase objectives are met
- Femoral venous anatomy that is unable to accommodate the introducer or the cardiac anatomy does not allow a leadless pacemaker in the right ventricle
- Morbid obesity which may prevent the LivIQ device from obtaining telemetry communication within a range of 20 cm, in the physician's judgement
- Intolerance of dexamethasone acetate
- 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
- Allergy to the materials of the leadless pacemaker or the implant tools that are in contact with the human body
- Prior leadless pacemaker implant attempt
- 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...
- 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...
- Planned ICD or CRT device implant
- Unstable angina pectoris or acute myocardial infarction within 30 days prior to enrollment
- Life expectancy of less than 12 months
- Unable to tolerate an urgent sternotomy
- 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
- Listed for or has received a heart transplantation or has a left ventricular assist device (LVAD)
- 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...
- Unable to attend in-person planned or emergent study site visits (e.g., frequent or extended travel plans)
- 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...
- Willing and able to perform the requested procedures for the AVS assessments
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Ypsilanti, Michigan, United States
- New York, New York, United States
- Winston-Salem, North Carolina, United States
- Paoli, Pennsylvania, United States
- Charlottesville, Virginia, United States
- Woolloongabba, Queensland, Australia
- Clayton, Victoria, Australia
- Bruges, Belgium
- Hasselt, Belgium
- Leuven, Belgium
- Liège, Belgium
- Clermont-Ferrand, France
- Paris, France
- Pessac, France
- Bad Nauheim, Hesse, Germany
- Bad Oeynhausen, North Rhine-Westphalia, Germany
- Kitakyushu, Fukuoka, Japan
- Suita, Osaka, Japan
- Nieuwegein, Netherlands
- The Hague, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ypsilanti, Michigan, United States; New York, New York, United States; Winston-Salem, North Carolina, United States; Paoli, Pennsylvania, United States; Charlottesville, Virginia, United States; Woolloongabba, Queensland, Australia and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.