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Набор скоро начнётся NCT06740539

Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs

Без фазы С лечением HFpEF - Heart Failure with Preserved Ejection Fraction 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
В протоколе указаны: Catheter ablation of atrial fibrillation.
Кому может быть актуально
Состояния в реестре: HFpEF - Heart Failure with Preserved Ejection Fraction, 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
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Обзор

A comparison of whether catheter ablation improves the prognosis (all-cause mortality and/or the composite endpoint of MACE) and reduces the recurrence rate of atrial fibrillation (AF) in patients with AF and heart failure with preserved ejection fraction (HFpEF), compared to anti-atrial arrhythmia drugs (AAD). This trial was randomly divided into two groups: the anti-AAD drug group and the catheter ablation group.

Вмешательства

  • Процедура Catheter ablation of atrial fibrillation
    Catheter ablation of atrial fibrillation

Первичные конечные точки

  • The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF. [Срок оценки: During regular follow-up visits at 3, 6, 12, 24months.]
Вторичные конечные точки (6)
  • All-Cause Mortality [Срок оценки: During regular follow-up visits at 3, 6, 12, 24months.]
  • Worsening of Heart Failure Requiring Unplanned Hospitalization [Срок оценки: During regular follow-up visits at 3, 6, 12, 24months.]
  • Cardiovascular Mortality [Срок оценки: During regular follow-up visits at 3, 6, 12, 24months.]
  • Unplanned Hospitalization due to Cardiovascular Reason [Срок оценки: During regular follow-up visits at 3, 6, 12, 24months.]
  • All-Cause Hospitalization [Срок оценки: During regular follow-up visits at 3, 6, 12, 24months.]
  • Cerebrovascular Accident [Срок оценки: During regular follow-up visits at 3, 6, 12, 24months.]

Критерии участия

Критерии включения

  • Age ≥18 years.
  • The patient is willing and able to comply with the protocol and has provided written informed consent.
  • Paroxysmal or persistent atrial fibrillation (AF).（Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than seven days but necessitating pharmacologic or electric cardioversion. Included within the category of persistent AF is 'long-standing persistent AF', defined as continuous AF of >1-year duration. AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter ECG, Loop Recorder, memory of the implanted device (ICD/CRT-D), or any other suitable device.）
  • Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs.
  • Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF).（(1) a history of hospitalization for HF with symptoms classified as New York Heart Association (NYHA) class II, III, or IV; (2) LVEF ≥ 50%; (3) at least one of the following cardiac structural abnormalities identified by echocardiography: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevated levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), with a threshold of ≥400 pg/mL for pa-tients with SR at admission and ≥600 pg/mL for patients with AF at admis-sion.)
  • New York Heart Association class II, III, or IV.

Критерии исключения

  • Previous left heart ablation procedure for AF.
  • Contraindication to chronic anticoagulation therapy or heparin.
  • Documented left atrial diameter >6 cm, optimally from the parasternal long-axis view.
  • Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment.
  • Planned cardiovascular intervention.
  • Listed for heart transplant.
  • Cardiac assist device implanted.
  • Life expectancy ≤ 12 months.
  • Mental or physical inability to participate in the study.
  • Requirement for dialysis due to terminal renal failure.
  • Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age.
  • Enrollment in another investigational drug or device study, or participation in another telemonitoring concept.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT06740539 · CAPHF-AF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗