Unipolar Voltage Mapping for Personalized Atrial Fibrillation Ablation

Официальное название

Unipolar Mapping for Personalized Atrial Fibrillation Ablation: An Interventional Study on Arrhythmia Maintenance and Atrial Remodeling

Обзор

Atrial fibrillation (AF) is a common heart rhythm disorder. While catheter ablation is an effective treatment, many patients still experience AF recurrence after the procedure. One major reason is that the mechanisms that maintain AF are not fully understood. Research suggests that the outer layer of the heart (epicardium) may play an important role in keeping AF going. However, current mapping techniques have limitations in detecting electrical signals from both the inner and outer heart layers. This study uses a different technique called unipolar voltage mapping, which may more accurately capture electrical signals from both heart layers. Specifically, we focus on a specific type of electrical signal called "QS potential" on unipolar mapping, which reflects breakthrough sites between the inner and outer heart layers. In this interventional study, participants with AF undergoing catheter ablation will receive personalized ablation guided by unipolar QS-potential mapping. We aim to: Explore the relationship between unipolar QS-potentials and AF maintenance and atrial remodeling Evaluate the effectiveness of QS-potential guided personalized AF ablation

Вмешательства

• Процедура Unipolar QS-Potential Guided Catheter Ablation
  Participants in this arm undergo catheter ablation for atrial fibrillation guided by unipolar QS-potential mapping. Intracardiac unipolar voltage mapping is performed to identify QS-potentials, which reflect epicardial-endocardial breakthrough sites. Ablation is delivered to these identified target sites in addition to standard pulmonary vein isolation.
• Процедура Conventional Pulmonary Vein Isolation
  Participants in this arm undergo conventional pulmonary vein isolation for atrial fibrillation using standard bipolar voltage mapping. Ablation is performed to achieve electrical isolation of the pulmonary veins, without additional mapping-guided ablation beyond PVI.

Первичные конечные точки

• Freedom from Atrial Fibrillation Recurrence at 3 Months Post Ablation [Срок оценки: 3 months (from month 1 to month 6 post-ablation)]

Вторичные конечные точки (1)

• Total ablation time [Срок оценки: Intraoperative (on the day of the ablation procedure)]

Критерии участия

Критерии включения

• Age ≥ 18 years and ≤ 80 years
• Documented diagnosis of atrial fibrillation (paroxysmal or persistent)
• Planned to undergo catheter ablation for AF (including patients with recurrent AF after prior ablation)
• Able and willing to provide written informed consent
• Able to complete scheduled follow-up visits (3 months post-ablation)

Критерии исключения

• Left ventricular ejection fraction < 35%
• Severe valvular heart disease (moderate to severe mitral stenosis or regurgitation)
• History of intracardiac thrombus
• Contraindication to anticoagulation
• Active infection or sepsis
• Pregnancy or breastfeeding
• Life expectancy < 12 months due to comorbid conditions
• Participation in another interventional clinical trial within 30 days prior to enrollment

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai Hospital — Пекин

Идентификаторы

NCT: NCT07630857 · 2026-3076

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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