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Идёт набор NCT07246135

Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten

— Наблюдательное Pacemaker Leadless Pacemaker Cardiac Pacing, Artificial Registries

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pacemaker, Leadless Pacemaker, Cardiac Pacing, Artificial, Registries. 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
Австрия
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 Pacemaker Registry

Обзор

The registry for leadless pacemakers will collect and annually analyze the data of all leadless pacemaker implantations at the University Hospital St. Pölten, including demographic information, indications, procedural details, acute, medium- and long-term complications during follow-up. Due to the partially novel nature of the signals (atrial mechanical sensing markers) and the lack of long-term experience to date, data on these aspects will also be collected and analyzed. This is a single-center, prospective and retrospective registry that includes all patients receiving a leadless pacing device, as well as all patients who received a leadless pacing device between January 2021 and the start of the registry. All patients undergoing implantation of a leadless pacemaker will be invited to participate in the registry. For patients to be included retrospectively, participation in the registry will be offered at the time of their next routine follow-up visit. The indication for leadless pacing will be determined by the physician responsible for the patient. Enrollment in the registry will in no case alter or influence the treatment the patient receives. Data collection will take place at the time of implantation and continuously during follow-up over the entire study period. Pacemaker-related data may be obtained either in person or via remote monitoring.

Первичные конечные точки

  • Procedural success rate [Срок оценки: Periprocedural / at Day 1]
  • Incidence of acute complications [Срок оценки: Within 30 days after implantation]
Вторичные конечные точки (12)
  • Device-related complication rate (medium- and long-term) [Срок оценки: Up to 10 years after implantation]
  • Ventricular pacing burden [Срок оценки: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter]
  • All-cause mortality [Срок оценки: Throughout follow-up (up to 10 years)]
  • Hospitalizations related to cardiac arrhythmias or heart failure [Срок оценки: Throughout follow-up (up to 10 years)]
  • Quality of Life after Implantation [Срок оценки: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter]
  • Electrical performance of the device [Срок оценки: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter]
  • Electrical performance of the device [Срок оценки: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter]
  • Electrical performance of the device [Срок оценки: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter]
  • Electrical performance of the device [Срок оценки: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter]
  • Left ventricular ejection fraction on Echocardiography [Срок оценки: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter]
  • Left ventricular dimensions on Echocardiography [Срок оценки: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter]
  • Right ventricular function on Echocardiography [Срок оценки: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter]

Критерии участия

Критерии включения

  • Patients undergoing implantation of a leadless pacemaker at the University Hospital of St. Pölten
  • Patients who previously received a leadless pacemaker between June 2015 and the start of the registry (retrospective inclusion).
  • Age ≥ 18 years.
  • Written informed consent provided by the patient.

Критерии исключения

  • Patients who decline or are unable to provide informed consent.
  • Patients in whom a conventional transvenous pacemaker is implanted (i.e., not leadless).
  • Any condition that, in the opinion of the treating physician, precludes participation in the registry.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Австрия · 1 центр
  • University Hospital of St. Pölten — Sankt Pölten

Идентификаторы

NCT: NCT07246135 · GS3-EK-4/899-2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗