Circumferential Pulmonary Vein Isolation With Modified Linear Ablation Versus Circumferential Pulmonary Vein Isolation Only in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 10
- 主要终点
- Freedom from any documented atrial arrhythmia off AADs
研究概览
简要总结
Catheter ablation has become as the first-line treatment for patients with symptomatic atrial fibrillation (AF). As the cornerstone of catheter ablation for AF, the safety and efficacy of circumferential pulmonary vein isolation (CPVI) have been confirmed. However, for persistent AF, especially for long-standing persistent AF (LSPAF), the recurrence rate is still high. Whether the ethanol infusion (EI) into the vein of Marshall (EI-VOM) and linear ablation could improve the success rate remains controversial.
The SINUS study is a prospective, multicenter, randomized trial, which is designed to compare the efficacy and safety between CPVI with modified linear ablation (CPVI-MLA) and CPVI only for the treatment of LSPAF.
详细描述
The SINUS study will include 320 patients with LSPAF undergoing catheter ablation for the first time. All patients will be randomized to either the CPVI-MLA group or CPVI only group in a 1:1 ratio. The CPVI-MLA strategy is a fixed ablation approach consisting of EI-VOM, CPVI, left atrial posterior wall isolation (PWI), linear ablation of mitral isthmus (MI), left atrial intima adjoining CS (LAI-CS) and cavo-tricuspid isthmus (CTI), and superior vena cava isolation (SVCI). The follow-up is for a minimum of 12 months with rhythm monitoring. The primary endpoint is freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) > 30 seconds after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), at 12 months after the index ablation procedure.
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)
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
- •1. Patients with symptomatic LSPAF refractory to at least one antiarrhythmic drug; LSPAF will be defined as a sustained AF episode lasting ≥ 1 year;
- •AF duration 1-3 years;
- •Age 18 - 75 years;
- •Left atrial diameter (LAD) 43-55 mm on long axis parasternal view;
- •AF recorded within 3 years of enrollment;
- •Patient willing and able to comply with protocol and sign informed consent
排除标准
- •Paroxysmal atrial fibrillation;
- •Persistent AF lasting < 1 year or >3 years;
- •Left atrial thrombosis;
- •Patients with a history of catheter ablation for AF;
- •Patients with severe structural heart disease (severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.);
- •LAD > 55mm on long axis parasternal view;
- •Left ventricular ejection fraction (LVEF) < 40%;
- •Patients with contraindications to low molecular weight heparin, warfarin or novel oral anticoagulants;
- •One-stop procedure for AF ablation and left atrial appendage occlusion;
- •Alcohol allergy or contrast agent allergy;
- •Patients taking cephalosporin antibiotics within 72 hours prior to ablation;
- •Pulmonary artery systolic pressure > 50mmHg;
- •Patients with unstable angina pectoris;
- •Patients who had undergone percutaneous coronary intervention (PCI) within 3 months;
- •Patients who had undergone surgery within 6 months;
- •Patients ready to receive heart transplantation;
- •Patients with a history of thromboembolism within 6 months;
- •Patients with diagnosed atrial myxoma;
- •Patients with severe respiratory diseases;
- •Patients with infectious diseases in active phase;
- •Patients with poorly controlled systemic immune diseases;
- •Patients with uncured malignant hematological diseases;
- •Patients with uncured malignant solid tumors;
- •Patients with untreated hypothyroidism or hyperthyroidism;
- •Patients with severe liver dysfunction (elevation of transaminases [ALT or AST] >3 times the upper limit of normal range);
- •Patients with end-stage renal failure requiring dialysis;
- •Patients with other serious arrhythmias, such as ventricular tachycardia with hemodynamic instability;
- •Pregnant and lactating women;
- •Patients with psychiatric ailments;
- •BMI < 18.5 or ≥ 30kg/m2;
- •Life expectancy < 2 years;
- •Patients unwilling or unable to give informed consent;
- •Patients unwilling or unable to cooperate to complete follow-up.
研究组 & 干预措施
CPVI-MLA
Patients randomized to the CPVI-MLA group first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by CPVI, left atrial posterior wall isolation (PWI), linear ablation of mitral isthmus (MI), left atrial intima adjoining CS (LAI-CS) and cavo-tricuspid isthmus (CTI), and superior vena cava isolation (SVCI).
干预措施: CPVI-MLA (Procedure)
CPVI only
Patients randomized to the CPVI group undergo right PV ablation, followed by the left PV ablation. Radiofrequency ablation should be applied at least 1-2 cm outside of the PV ostia in a wide-area circumferential pattern. Complete CPVI is achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished.
干预措施: CPVI only (Procedure)
结局指标
主要结局
Freedom from any documented atrial arrhythmia off AADs
时间窗: 12 months
Freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) \> 30 seconds assessed by ECG and Holter after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), after the index ablation procedure
次要结局
- Freedom from AF after multiple procedures(12 months)
- Freedom from AFL/AT after multiple procedures(12 months)
- AFEQT score change between baseline and 12-month(12 months)
- Freedom from any documented atrial arrhythmia on/off AADs(12 months)
- Freedom from any documented AF on/off AADs(12 months)
- AF burden(12 months)
- Freedom from any documented AFL/AT on/off AADs in patients with successful EI-VOM(12 months)
- AF burden in patients with successful EI-VOM(12 months)
- AF burden after multiple procedures(12 months)
- Freedom from any documented AFL/AT on/off AADs(12 months)
- EQ-5D-5L score change between baseline and 12-month(12 months)
- Freedom from AF/AFL/AT after multiple procedures(12 months)
- Hospitalization for cardiovascular disease(12 months)
- Incidence of procedural complications(Within 3 months after the procedure)
研究者
Zhang Fengxiang
Deputy Director of Cardiology, Principal Investigator, Clinical Professor
The First Affiliated Hospital with Nanjing Medical University