A Multicenter, Prospective, Randomized Controlled Trial of Combined Pulsed-Field and Radiofrequency-Modified Linear Ablation Versus Pulsed-Field Ablation Alone for Long-Standing Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 430
- 试验地点
- 3
研究概览
简要总结
The goal of this clinical trial is to test if a more complete ablation procedure works better than the standard procedure for people with long-lasting persistent atrial fibrillation (AF). AF is a heart rhythm problem that can cause a fast or uneven heartbeat.
This study will include 430 people with long-lasting AF that has lasted 1 to 3 years. Participants will be put into one of two groups by chance:
First group (control): They will receive pulsed-field ablation (PFA), a type of energy that can stop the faulty heart signals. They will have isolation of the pulmonary veins and the posterior wall of the left atrium.
Second group (study): They will receive the same PFA procedure plus extra ablation lines (modified linear ablation) using radiofrequency energy. This includes ablation of the mitral isthmus (with ethanol infusion into a small vein called the vein of Marshall) and the cavotricuspid isthmus.
Participants will be followed for 12 months after the procedure with clinic visits, electrocardiograms (ECGs), and heart rhythm monitors. The main outcome is whether participants stay in normal heart rhythm (sinus rhythm) without any AF episodes lasting more than 30 seconds at 12 months. Researchers will also look at procedure time, complication rates, quality of life, and other rhythm outcomes.
This study will help show if the more complete ablation procedure leads to better long-term results for people with long-lasting AF.
详细描述
Atrial fibrillation (AF), often called AFib, is the most common type of irregular heartbeat. Normally, the heart beats in a steady rhythm. In AF, the upper chambers of the heart (the atria) beat very fast and irregularly, which prevents blood from being pumped out completely. People with AF may feel heart palpitations (a racing or fluttering feeling), dizziness, shortness of breath, fatigue, and chest discomfort. Over time, AF increases the risk of blood clots, stroke, heart failure, and other serious health problems.
What is long-standing persistent AF?
AF is classified by how long it lasts. This study focuses on long-standing persistent AF, which is defined as continuous AF that lasts for more than 12 months. In this form of AF, the heart's upper chambers have undergone significant changes-often called "atrial remodeling." These changes make the heart tissue more prone to sustaining irregular rhythms and make the condition harder to treat compared to shorter-lasting forms of AF. Many patients with long-standing persistent AF continue to have symptoms even after trying antiarrhythmic medications (drugs designed to control heart rhythm), and finding an effective treatment remains a challenge.
Why is this study needed?
Catheter ablation is a procedure that uses energy to create small scars in specific areas of the heart to block abnormal electrical signals. Pulmonary vein isolation (PVI) is the standard ablation procedure for AF, where the doctor isolates the areas where most abnormal signals start. However, in patients with long-standing persistent AF, PVI alone is often not enough. Studies show that only about half of patients remain in normal heart rhythm 12 months after PVI alone. Researchers believe that additional ablation lines-created along specific pathways outside the pulmonary veins-may help block more abnormal electrical circuits and improve outcomes. The main challenge is that doctors do not yet know which combination of ablation lines works best.
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 (Outcomes Assessor)
盲法说明
This is a single-blind study. Participants are blinded to their assigned treatment group (control vs. study). Procedure operators are not blinded due to the nature of the interventions. All other study personnel involved in outcome assessment (e.g., ECG core laboratory, Holter analysis) and statistical analysis are blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic patients with long-standing persistent atrial fibrillation.
- •Duration of atrial fibrillation between 1 and 3 years.
- •Age 18 to 75 years.
- •Documentation of atrial fibrillation within 3 years prior to enrollment.
- •Willing and able to comply with the study protocol and provide written informed consent.
排除标准
- •Paroxysmal atrial fibrillation, or evidence of sinus rhythm on electrocardiogram within the past year.
- •Persistent atrial fibrillation lasting less than 1 year or more than 3 years.
- •Left atrial thrombus.
- •Prior catheter ablation for atrial fibrillation.
- •Coexisting severe organic heart disease (e.g., severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.).
- •Left atrial diameter (LAD) >55 mm.
- •Left ventricular ejection fraction (LVEF) <40%.
- •Known allergy or contraindication to low-molecular-weight heparin, warfarin, or direct oral anticoagulants.
- •Undergoing a "one-stop" procedure combining atrial fibrillation ablation with left atrial appendage closure.
- •Allergy to alcohol or contrast media.
- •Pulmonary artery systolic pressure >50 mmHg.
- •Unstable angina pectoris.
- •Percutaneous coronary intervention (PCI) within the past 3 months.
- •Cardiac surgery within the past 6 months.
- •Planned heart transplantation.
- •History of thromboembolic disease within the past 6 months (including venous thromboembolism: pulmonary embolism, deep vein thrombosis; or arterial thromboembolic disease: acute coronary syndrome, lower extremity arterial embolism, stroke).
- •Left atrial myxoma.
- •Severe respiratory disease.
- •Active infectious disease.
- •Poorly controlled or active systemic immune disease (equivalent to glucocorticoid use >2 tablets/day).
- •Unresolved malignant hematologic disease, or currently receiving chemotherapy, radiotherapy, or immunotherapy.
- •Unresolved malignant solid tumor, or currently receiving chemotherapy, radiotherapy, or immunotherapy.
- •Untreated hypothyroidism or hyperthyroidism.
- •Severe hepatic insufficiency (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 times the upper limit of normal).
- •End-stage renal failure requiring dialysis.
- •Other serious arrhythmias, such as hemodynamically unstable ventricular tachycardia.
- •Pregnancy or breast-feeding.
- •Psychiatric disorder.
- •Body mass index (BMI) <18.5 or >35.0 kg/m².
- •Life expectancy <2 years.
研究组 & 干预措施
PVI + Posterior Wall + Modified Linear Ablation (PFA + RF)
Participants in this arm receive the same PFA-based pulmonary vein isolation and posterior wall box isolation as the control arm. In addition, they undergo modified linear ablation using radiofrequency (RF) energy. This includes:
Mitral isthmus line supplemented by ethanol infusion into the vein of Marshall.
Cavotricuspid isthmus line. The goal is to achieve bidirectional block across all ablation lines.
干预措施: Radiofrequency Ablation Catheter (Procedure)
研究者
Yunlong Wang
Principal Investigator, Department of Cardiology
Beijing Anzhen Hospital