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Идёт набор NCT06987825

Chinese Atrial Fibrillation Registry

— Наблюдательное Atrial Fibrillation (AF)

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: Atrial Fibrillation (AF). 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This prospective, observational cohort study aims to establish a long-term registry of adult patients with atrial fibrillation (AF) in China to comprehensively characterize patient profiles and evaluate real-world management and outcomes over time. The objectives of the study are to: * Describe the demographic, clinical, and treatment characteristics of AF patients across different stages of disease progression. * Assess the effectiveness and safety of various AF treatment strategies, including oral anticoagulation, catheter ablation, and left atrial appendage closure, in routine clinical practice. * Identify patient- and treatment-related factors that influence therapeutic outcomes. * Explore the role of advanced technologies and artificial intelligence in improving procedural performance, risk stratification, and clinical decision-making in AF care. Participants will undergo standardized baseline evaluation and longitudinal follow-up to collect data on heart rhythm monitoring, treatment exposures, healthcare utilization, clinical events, and patient-reported outcomes. This cohort will generate real-world evidence to inform personalized and evidence-based management of AF.

Подробное описание

This prospective, multicenter observational registry aims to collect standardized clinical data on adults with atrial fibrillation (AF) across over 30 hospitals in China. The study reflects real-world clinical practice and does not interfere with treatment decisions.

Baseline and follow-up data will be collected using standardized forms, including demographics, medical history, cardiovascular risk factors, laboratory and imaging results, medication use, and-when applicable-procedural details for catheter ablation, such as energy source and complications.

Follow-up will be conducted at 1, 2, 3, and 6 months after enrollment, and every 6 months thereafter. Data include ECG monitoring, medication updates, hospitalizations, adverse events (e.g., stroke, bleeding, cardiovascular death), and healthcare utilization. Quality of life, cognitive, and psychological assessments may also be collected.

All treatments are determined by physicians as part of usual care. The registry provides internal feedback on potential treatment issues and generates periodic, anonymized summaries for participating centers.

The study aims to inform clinical practice and support real-world evidence generation to improve AF management in China.

Первичные конечные точки

  • All-cause death [Срок оценки: 10 years]
Вторичные конечные точки (9)
  • Ischemic Stroke [Срок оценки: 5 years]
  • Hemorrhagic Stroke [Срок оценки: 5 years]
  • Transient ischemic attack (TIA) [Срок оценки: 5 years]
  • Cardiovascular Death [Срок оценки: 5 years]
  • Cardiovascular Hospitalization [Срок оценки: 5 years]
  • Systemic Embolism [Срок оценки: 5 years]
  • Thromboembolic Death [Срок оценки: 5 years]
  • Major Bleeding [Срок оценки: 5 years]
  • Clinically Relevant Non-Major Bleeding (CRNMB) [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Age ≥ 18 years;
  • Documented atrial fibrillation episode lasting >30 seconds confirmed by electrocardiogram (ECG), Holter monitor, implantable cardiac monitor, or wearable ECG device
  • Signed informed consent and willingness to participate in follow-up

Критерии исключения

  • Atrial fibrillation due to a reversible cause (e.g., transient secondary AF)
  • Presence of comorbid conditions associated with an expected life expectancy of less than 1 year

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 2 центра
  • Beijing Anzhen Hospital — Пекин
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Ханчжоу

Публикации

  • Ren L, Peng X, Li M, He L, Zhou N, Liu X, Zuo S, Dong J, Ma C, Guo X. Association of left ventricular geometry with outcomes and treatment response in atrial fibrillation and heart failure with preserved ejection fraction. Front Med (Lausanne). 2026 May 4;13:1824509. doi: 10.3389/fmed.2026.1824509. eCollection 2026. PMID 42158122

Идентификаторы

NCT: NCT06987825 · KS2025087

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗