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Идёт набор NCT07287423

LEAP 2 Chronic EFS

Без фазы С лечением Cardiac Pacemaker Cardiac Rhythm Disorder Bradycardia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AVEIR CSP Leadless Pacemaker System.
Кому может быть актуально
Состояния в реестре: Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

LEadless Advanced Pacing 2 Chronic Early Feasibility Study

Обзор

Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.

Подробное описание

The purpose of this clinical investigation is to evaluate the chronic safety and performance of the AVEIR CSP Leadless Pacemaker system in a patient population with standard pacing indications.

Subjects participating in the study will have data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 2 months, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion

Вмешательства

  • Устройство AVEIR CSP Leadless Pacemaker System
    Patients will undergo a single or dual-chamber leadless pacemaker system implant wherein an investigational AVEIR CSP leadless pacemaker will be implanted in the right ventricle. Then, a commercial AVEIR AR leadless pacemaker may optionally be co-implanted in the right atrium, if indicated.

Первичные конечные точки

  • Percentage of Participants Free From AVEIR CSP related Complications at 1-month [Срок оценки: 1 month]
  • Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 1-month [Срок оценки: 1 month]
Вторичные конечные точки (2)
  • Percentage of Participants Free From AVEIR CSP related Complications at 3-months [Срок оценки: 3 months]
  • Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 3 months [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • Subject must have at least one standard pacemaker indication
  • Subject must be at least 18 years of age
  • Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
  • Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, as approved by the local EC

Критерии исключения

  • Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter
  • Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure
  • Subject has previous myocardial infarction
  • Subject is expected to be pacemaker dependent
  • Subject has a previous or existing lead or device in the right heart or interventricular septum (includes lead fragments, temporary pacing leads, and closure devices)
  • Subject has an active implantable electronic device that cannot be turned off during the study procedure
  • Subject has recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
  • Subject has known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material used in the study procedure
  • Subject is unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
  • Subject has known chronic renal insufficiency including patients on dialysis
  • Subject has an active systemic infection
  • Subject has known history or repair of an atrial septal defect, patent foramen ovale, or ventricular septal defect
  • Subject is currently participating in another clinical investigation that might impact the outcomes of the clinical investigation
  • Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the follow-up requirements of the clinical investigation
  • Subject is unable to read or write

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

Чехия · 1 центр
  • Nemocnice Na Homolce — Prague

Идентификаторы

NCT: NCT07287423 · ABT-CIP-10614

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗