Comparison of Catheter Ablation Combined With Ethanol Ablation of the Marshall Vein vs. Catheter Ablation Alone in Persistent Atrial Fibrillation With Heart Failure: A Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Freedom from Atrial Fibrillation/Atrial Flutter (AT/AF) Recurrence
研究概览
简要总结
This multicenter, randomized controlled trial aims to compare the clinical efficacy and safety of combining catheter ablation with Marshall vein ethanol ablation versus catheter ablation alone in patients with persistent atrial fibrillation (AF) and concomitant heart failure. Persistent AF is a common arrhythmia that significantly impacts the quality of life and survival rates, especially when coexisting with heart failure. While catheter ablation is a standard treatment for AF, its effectiveness in persistent AF, particularly in patients with heart failure, remains suboptimal. The addition of Marshall vein ethanol ablation may enhance treatment outcomes by targeting arrhythmogenic substrates. This study will enroll 120 participants across three centers to evaluate whether this combined approach can reduce AF recurrence, improve heart function, and enhance patient outcomes compared to catheter ablation alone.
详细描述
Persistent atrial fibrillation (AF) combined with heart failure presents a significant clinical challenge due to the high rates of morbidity and mortality associated with these conditions. Catheter ablation is widely used to manage AF, but its efficacy in persistent AF, particularly in patients with heart failure, is limited. Recent advances suggest that targeting the Marshall vein with ethanol ablation may offer additional benefits by disrupting critical pathways involved in AF maintenance.
This study is designed to evaluate the efficacy of combining Marshall vein ethanol ablation with standard catheter ablation compared to catheter ablation alone in a well-defined patient population. Conducted across three centers, this randomized controlled trial will rigorously assess whether the combined approach can offer superior outcomes, including lower AF recurrence rates and improved heart function. The study's findings are expected to contribute valuable insights into optimizing treatment strategies for this high-risk patient group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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 between 18 and 80 years
- •For symptomatic patients with persistent atrial fibrillation: At least a 6-month history of atrial fibrillation; atrial fibrillation duration exceeding 7 days without spontaneous conversion to sinus rhythm; at least two episodes of persistent atrial fibrillation in the past 6 months even after rhythm conversion; poor tolerance or resistance to at least one Class I, II, or III antiarrhythmic drug
- •Diagnosed with heart failure: Echocardiogram showing left ventricular ejection fraction (LVEF) ≤40%
- •Patient willing to receive medication or surgical treatment
- •Patient willing to comply with the requirements before the study, during the study, and during follow-up and to sign an informed consent form
- •Capable of completing a 6-minute walk test
- •For women of childbearing potential, a negative pregnancy test result is required
排除标准
- •Presence of thrombus in the left atrium
- •Left atrial diameter greater than 65 millimeters in the parasternal long-axis view, or left atrial volume exceeding 200 milliliters as measured by MRI or CT
- •Presence of significant congenital abnormalities or medical issues, deemed by the researcher as inappropriate for participation in the study
- •Reversible causes of atrial fibrillation, such as pericarditis, thyroid disease, acute alcohol intoxication, recent major surgery, or trauma
- •Currently suffering from valvular heart disease requiring surgical intervention
- •Currently suffering from coronary artery disease requiring surgical or percutaneous intervention
- •History of atrioventricular node ablation
- •Liver failure
- •Renal failure requiring dialysis
- •Contraindicated use of appropriate anticoagulation therapy
- •Participation in other experimental drug or device studies
- •Severe pulmonary disease
- •Previous catheter ablation for atrial fibrillation in the left atrium
- •Documented thromboembolic event within the past 90 days
- •Pregnant women
结局指标
主要结局
Freedom from Atrial Fibrillation/Atrial Flutter (AT/AF) Recurrence
时间窗: 12 months after the procedure
The primary outcome is the proportion of participants who remain free from clinical recurrence of atrial fibrillation (AF) or atrial flutter (AFL) at follow-up. Recurrence is defined as the absence of documented AF/AFL episodes lasting 30 seconds or more during continuous ECG monitoring over a 1-month period.
Change in Left Ventricular Ejection Fraction (LVEF)
时间窗: 12 months after the procedure
This outcome assesses the change in LVEF as measured by echocardiography, reflecting the effect of the intervention on cardiac function.
Change in NT-proBNP Levels
时间窗: 12 months after the procedure
This outcome measures the change in NT-proBNP levels, a biomarker for heart failure, from baseline to follow-up, indicating the impact of the intervention on heart failure status.
Change in 6-Minute Walk Test Distance
时间窗: 12 months after the procedure
This outcome measures the change in the distance covered during the 6-minute walk test, an indicator of functional capacity and exercise tolerance.
Change in NYHA Functional Class
时间窗: 12 months after the procedure
This outcome evaluates changes in the New York Heart Association (NYHA) functional classification, which assesses the severity of heart failure symptoms and functional limitations.
次要结局
- Presence or Absence of Palpitations Within 30 Days(30 days after the procedure)
- Presence or Absence of Bleeding Within 30 Days(30 days after the procedure)
- Presence or Absence of Mortality Within 30 Days(30 days after the procedure)
- Total Number of Procedures Performed(During the procedure(s))
- Atrial Fibrillation Burden at 6 Months(6 months after the procedure)
- Total Radiofrequency Ablation Time for the First Procedure(During the first procedure)
- Total Area of Left Atrial (LA) Tissue Ablated(During the procedure(s))
- Presence or Absence of Arrhythmias Within 30 Days(30 days after the procedure)
- Presence or Absence of Chest Tightness Within 30 Days(30 days after the procedure)
- Atrial Fibrillation Burden at 12 Months(12 months after the procedure)
- Total Radiofrequency Ablation Time for the Second Procedure (if applicable)(During the second procedure)
研究者
Li Xuping
Chief Physician
Second Xiangya Hospital of Central South University