BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство LivIQ Leadless Pacemaker System
  Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.

Первичные конечные точки

• Freedom from Serious Adverse Device Effects [Срок оценки: 3 months]
• Percentage of Subjects with Adequate Pacing [Срок оценки: 3 months]
• Percentage of Subjects with Adequate Pacing and Sensing [Срок оценки: 3 months]

Вторичные конечные точки (10)

• Improvement in SF-36 Role Physical Scale [Срок оценки: Baseline and 6 months]
• Ventricular Capture Control Operation [Срок оценки: 3 months]
• Rate Response Operation [Срок оценки: 3 months]
• SADEs Related to the LivIQ System and/or Procedure [Срок оценки: 3, 6, 12 months]
• Pacing Performance [Срок оценки: 6, 12 months]
• Pacing and Sensing Performance [Срок оценки: 6, 12 months]
• Health-Related Quality of Life - EQ-5D-5L [Срок оценки: Baseline, 3, 6 months]
• Health-Related Quality of Life - SF-36 [Срок оценки: Baseline, 3, 6 months]
• Battery Longevity [Срок оценки: 12 months]
• 2-Year Survival Rate [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 temporary transvenous pacemakers
• 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.
• 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 of the study Note: Co-enrollment in concurrent trials is only allowed when documented prior approval is obtained from BIOTRONIK
• 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 criteria:

• 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 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• Sutter Health — Burlingame
• MemorialCare Saddleback Medical — Laguna Hills
• Trinity Health Ann Arbor Hospital — Ypsilanti
• NY Presbyterian Weill Cornell Medicine — New York
• Wake Forest University Health — Winston-Salem
• Cardiology Consultants of Philadelphia — Paoli
• UVA Health University Medical Center — Charlottesville

Бельгия · 4 центра

• AZ Sint-Jan — Bruges
• Jessa Ziekenhuis — Hasselt
• UZ Leuven Gasthuisberg — Leuven
• CHR de la Citadelle - Liège — Liège

Франция · 3 центра

• Hôpital Gabriel Montpied, Clermont Ferrand — Clermont-Ferrand
• Hôpital Europeén Georges Pompidou — Paris
• Hôpital Haut Lévêque (CHU) — Pessac

Германия · 3 центра

• Kerckhoff-Klinik GmbH — Bad Nauheim
• Herz- und Diabeteszentrum NRW — Bad Oeynhausen
• Heinrich-Heine Universität Düsseldorf — Düsseldorf

Австралия · 2 центра

• Princess Alexandra Hospital — Woolloongabba
• Victorian Heart Hospital — Clayton

Япония · 2 центра

• Kokura Memorial Hospital — Kitakyushu
• National Cerebral and Cardiovascular Center Hospital — Suita

Нидерланды · 2 центра

• Research & Innovation Heart Centre St. Antonius Ziekenhuis — Nieuwegein
• HagaZiekenhuis van Den Haag - Leyweg — The Hague

Идентификаторы

NCT: NCT07118358 · BIO-LivIQ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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