Unipolar Mapping for Personalized Atrial Fibrillation Ablation: An Interventional Study on Arrhythmia Maintenance and Atrial Remodeling
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
QS-Guided Ablation Group
Participants in this arm undergo catheter ablation for atrial fibrillation guided by unipolar QS-potential mapping. Ablation is delivered to these identified target sites in addition to standard pulmonary vein isolation.
干预措施: Unipolar QS-Potential Guided Catheter Ablation (Procedure)
Conventional PVI Group
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.
干预措施: Conventional Pulmonary Vein Isolation (Procedure)
研究者
Yuhe Jia
Chief Physician, Department of Cardiology
China National Center for Cardiovascular Diseases