Empirical Anatomy-Based Ablation vs Emphasize Map-Guided Substrate Ablation in Persistent Atrial Fibrillation : (COMPASS-AF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Recurrence of atrial tachyarrhythmia
研究概览
简要总结
This study is aimed to compare the clinical efficacy of two different catheter ablation strategies in patients with persistent atrial fibrillation.
Participants will be randomized 1:1 into either the Anatomy-based group or the Emphasize map-guided group
- Anatomy-based group : Pulmonary vein isolation (PVI) using pulsed-field ablation (PFA) with a single-shot multielectrode catheter.
- Emphasize map-guided group : PVI using radiofrequency (RF) ablation followed by additional EnSite X-guided pathologic substrate modification.
Participants will be followed for 1 year to compare the incidence of any atrial tachyarrhythmia and other clinical parameters between the two groups.
详细描述
Pulsed-field ablation (PFA) is increasingly being adopted in clinical practice due to its advantages in shortening procedure times and reducing the incidence of complications. While the majority of PFA-related research has focused on PVI-centric strategies, recent studies have reported that posterior wall isolation (PWI) using PFA can also be performed safely. However, sufficient clinical evidence regarding the efficacy of additional ablation strategies beyond PVI in patients with persistent atrial fibrillation (AF) has yet to be established.
The Emphasize mapping system, a software feature within the EnSite X platform, is designed to simultaneously visualize Voltage maps, Peak frequency, and CFAE-related information. Unlike the individual analysis of each parameter, this integrated approach allows for a more precise identification of electrophysiologically significant pathologic substrates by evaluating the complex characteristics of electrical signals holistically. Currently, however, Emphasize-guided ablation is technically limited to the use of radiofrequency (RF) energy.
Persistent AF is characterized by complex and heterogeneous mechanisms, meaning a single, uniform ablation strategy may not yield consistent clinical outcomes across all patients. Consequently, it is hypothesized that an individualized substrate ablation strategy guided by functional mapping may be more effective than a conventional, empirical anatomy-based approach.
Therefore, this study aims to compare the clinical efficacy and safety of an empirical anatomy-based ablation strategy using PFA versus an individualized Emphasize map-guided substrate ablation strategy in patients with persistent AF.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older who have voluntarily provided written informed consent to participate in the study
- •Patients diagnosed with persistent atrial fibrillation (AF) who are scheduled to undergo catheter ablation for AF.
排除标准
- •History of prior catheter ablation or MAZE surgery for atrial fibrillation.
- •Left atrial (LA) diameter exceeding 60 mm.
- •Patients with end-stage renal disease (ESRD).
- •History of prior open-heart surgery.
- •Women who are pregnant, lactating, or of childbearing potential.
- •Heart failure corresponding to New York Heart Association (NYHA) functional class IV.
- •Acute coronary syndrome (ACS) experienced within the past 3 months.
- •Patients with terminal illness and a life expectancy of less than one year.
- •Any other condition that the investigator deems inappropriate for participation in the study.
结局指标
主要结局
Recurrence of atrial tachyarrhythmia
时间窗: From 3 months to 12 months after the index procedure
Any documented atrial tachyarrhythmias excluding the initial 3-month blanking period. Documented atrial tachyarrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia) were defined as follows: * Atrial tachyarrhythmias documented in 12 lead ECG * Atrial tachyarrhythmias of more than 30 seconds in Holter monitoring Recorded as a binary outcome (presence or absence of recurrence)
次要结局
- Atrial fibrillation burden(From 3 months to 12 months after the index procedure)
- Repeat ablation(From index procedure to 12 months)
- Use of antiarrhythmic drug therapy(From 3 months to 12 months after the index procedure)
- Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire score(From index procedure to 12 months)
- Stroke(From index procedure to 12 months)
- Cardiovascular hospitalization(From index procedure to 12 months)
- Bleeding event(From index procedure to 12 months)
- All-cause mortality(From index procedure to 12 months)
- Procedure-related complications(From index procedure to 30days)
- Procedure time(at the index procedure)
- Radiation time(at the index procedure)
- Left atrial reservoir strain(From index procedure to 12 months)
研究者
Ju Youn Kim
Professor
Samsung Medical Center
