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Набор скоро начнётся NCT07627685

Prospective Study on the Effectiveness and Safety of Bi-polar Pulse-field Tip-catheter Ablation for Atrial Fibrillation in China（POTENTIAL-AF）

— Наблюдательное Atrial Fibrillation

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: Bi-polar Pulse-field Ablation (PFA) - LEAD-PFA System with PulsedFA catheter.
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation. 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

POTENTIAL-AF is a prospective, multicentre, observational registry study evaluating the real-world effectiveness and safety of bi-polar pulse-field tip-catheter ablation (PFA) for atrial fibrillation (AF) in China. The study will enrol 30,000 adult patients with symptomatic paroxysmal or persistent AF who have failed at least one antiarrhythmic drug (Class I or III) and are planned to undergo PFA using the Jinjiang LEAD-PFA system with PulsedFA catheter at participating centres across China. All procedural decisions, including energy settings, ablation targets, and peri-procedural management, are made by the treating physician per routine clinical practice. The study prospectively collects baseline clinical characteristics, intraoperative ablation parameters, and follow-up outcomes at 3 months, 6 months, 12 months, and every 6 months thereafter, for up to 10 years. The primary endpoint is all-cause mortality at 10 years. Secondary endpoints (observed over 5 years) include ischaemic stroke, haemorrhagic stroke, transient ischaemic attack (TIA), cardiovascular death, cardiovascular hospitalisation, systemic embolism, thromboembolic death, major bleeding, and clinically relevant non-major bleeding (CRNMB). By capturing large-scale, standardised, long-term data across diverse Chinese centres, POTENTIAL-AF aims to describe real-world procedural practice patterns, identify predictors of clinical outcomes, and provide evidence to support the safe and effective application of the Jinjiang bi-polar tip PFA catheter in Chinese AF patients.

Вмешательства

  • Устройство Bi-polar Pulse-field Ablation (PFA) - LEAD-PFA System with PulsedFA catheter
    Participants undergo catheter ablation for atrial fibrillation using the Jinjiang bi-polar pulse-field ablation (PFA) system, comprising the LEAD-PFA generator and PulsedFA circular catheter (Jinjiang Electronic Medical Technology Co., Ltd., Sichuan, China). Catheter size (15 mm, 18 mm, or 25 mm) is selected by the operator based on individual anatomy. All patients undergo pulmonary vein isolation (PVI) as the mandatory ablation target. A minimum of 12 PFA applications are delivered per pulmona

Первичные конечные точки

  • All-Cause Mortality [Срок оценки: From enrolment to 10 years]
Вторичные конечные точки (9)
  • Ischaemic Stroke [Срок оценки: 5 years from enrolment]
  • Haemorrhagic Stroke [Срок оценки: 5 years from enrolment]
  • Transient Ischaemic Attack (TIA) [Срок оценки: 5 years from enrolment]
  • Cardiovascular Death [Срок оценки: 5 years from enrolment]
  • Cardiovascular Hospitalisation [Срок оценки: 5 years from enrolment]
  • Systemic Embolism [Срок оценки: 5 years from enrolment]
  • Thromboembolic Death [Срок оценки: 5 years from enrolment]
  • Major Bleeding (ISTH Definition) [Срок оценки: 5 years from enrolment]
  • Clinically Relevant Non-Major Bleeding (CRNMB) [Срок оценки: 5 years from enrolment]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Symptomatic paroxysmal AF or persistent AF:
  • Paroxysmal AF: self-terminating within ≤ 7 days; ≥ 2 symptomatic episodes in the 6 months prior to enrolment; ≥ 1 ECG or Holter-documented AF episode in the 12 months prior to enrolment
  • Persistent AF: duration > 7 days and < 1 year; ≥ 1 symptomatic episode in the 6 months prior; documented by Holter or 2 ECGs ≥ 7 days apart within 12 months prior
  • Failure of AAD therapy: inadequate efficacy and/or intolerance to ≥ 1 Class I or Class III antiarrhythmic drug
  • Planned PFA catheter ablation for AF
  • Voluntary participation with written informed consent Willing and able to comply with study procedures and follow-up (including in-hospital assessment, 30-day and 90-day follow-up)

Критерии исключения

  • AF attributable to a reversible cause (e.g., hyperthyroidism, peri-operative or cardiac/thoracic surgery-related AF)
  • Concomitant condition with expected survival < 1 year (e.g., advanced malignancy)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Anzhen Hospital — Пекин

Идентификаторы

NCT: NCT07627685 · POTENTIAL-AF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗