Меню
Идёт набор NCT06854484

AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry

— Наблюдательное Bradycardia Atrio-Ventricular Block Syncope

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™leadless pacemaker.
Кому может быть актуально
Состояния в реестре: Bradycardia, Atrio-Ventricular Block, Syncope. 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
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

AVEIR™ Leadless Pacemaker United Kingdom Registry

Обзор

This observational study will follow patients requiring implantation of leadless pacemaker for 5 years after implantation. The main goal is to evaluate the long term safety and efficacy of AVEIR™ leadless pacemaker device in the usual clinical settings within the UK National Health Service. In addition, the study will collect data to understand patient characteristics receiving this type of pacemaker.

Подробное описание

AVEIR™ stimulator (Abbott) obtained the approvals in July 2023 and started to be implanted in patients in Europe. As a leadless pacemaker, the AVEIR™ Leadless Pacemaker (LP) does not need a connector, pacing lead, or pulse generator pocket. The LP is delivered percutaneously via the femoral vein through an AVEIR™ Introducer and Delivery Catheter. AVEIR™ LP is intended to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target treatment group.

The purpose of this study is to understand long term safety and performance characteristic of this device. In addition, the study will collect anonymous clinical data and characteristics of the patients chosen to be implanted with AVEIR™ leadless pacemaker in routine clinical practice in approved centres across the UK.

Six hundred patients will be recruited in up to 15 centres during 2 years recruitment period. They will be followed up for 5 years after implantation of the leadless pacemaker. Investigators will record their age, sex, medical history, indications for receiving AVEIR™ and any complications related to the implantation procedure or the device itself. All the data will be collected in an anonymous format. Patients will be followed up according to the standard of care in the national health care system.

Вмешательства

  • Устройство AVEIR™leadless pacemaker
    AVEIR™ leadless pacemaker implantation

Первичные конечные точки

  • Percentage of patients without complications related to the device or implantation procedure. [Срок оценки: 5 years]
  • Percentage of patients requiring re-intervention. [Срок оценки: 5 years]
  • Stimulation threshold (V) in the therapeutic zone [Срок оценки: 5 years]
  • Percentage of stimulation in the therapeutic zone [Срок оценки: 5 years]
  • Impedance (Ohm) of R waves in the therapeutic zone [Срок оценки: 5 years]
  • Amplitudes of R waves (mV) in the therapeutic zone [Срок оценки: 5 years]
Вторичные конечные точки (4)
  • Age of patient (years) at AVEIR ™ leadless pacemaker implantation [Срок оценки: 5 years]
  • Sex of patient at AVEIR ™ leadless pacemaker implantation [Срок оценки: 5 years]
  • Medical history at AVEIR ™ leadless pacemaker implantation [Срок оценки: 5 years]
  • Indications for AVEIR ™ leadless pacemaker implantation [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Patient is intended to receive or was treated with a (AVEIR™) Leadless Transcatheter Pacing
  • Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
  • Subject has been informed of the nature of the study, agrees to its provisions, and has provided a signed written informed consent, approved by the Regional Ethics Committee (REC).

Критерии исключения

  • Subject is not suitable for implantation of the leadless device according to the expert opinion of their cardiologist.
  • Subject is not willing to comply with clinical investigation procedures and does not agree to return for all required follow-up visits, tests, and exams
  • Subject has been informed of the nature of the study, but does not agree to its provisions, and has not provided a signed written informed consent, approved by the REC

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 2 центра
  • Royal Brompton Hospital — London
  • The Royal Brompton Hospital — London

Идентификаторы

NCT: NCT06854484 · AVEIR™ Registry · Medical Affairs CR24562

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗