Complex Arrhythmia Registry（CAR）： Long-term Outcomes of Catheter Ablation for Atrial Fibrillation or Ventricular Tachycardia： A Multicenter， Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 3
- 主要终点
- Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure
研究概览
简要总结
This is a prospective, non-randomized, multicenter observational registry study designed to systematically evaluate the long-term efficacy and safety of catheter ablation for treating atrial fibrillation (AF) and ventricular tachycardia (VT) in Chinese patients.
详细描述
With the advancement of cardiac electrophysiology, the latest radiofrequency ablation technologies have played a significant role in the treatment of AF and VT. However, long-term outcome data on the application of these advanced techniques in Chinese patients still remains limited. The prospective, non-randomized, multicenter observational registry study will be divided into two cohorts:
- The AF Cohort will focus on evaluating the effectiveness and safety of different ablation workflows. It aims to redefine the relationship between AF recurrence and long-term outcomes using AF burden, thereby further optimizing treatment strategies for AF.
- The VT Cohort will primarily assess the application effects of novel technologies in VT treatment.
These data will provide critical reference information for future diagnostic and management strategies for complex arrhythmias.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrial Fibrillation (AF) Cohort:
- •Inclusion Criteria (Patients must meet ALL of the following criteria):
- •Age ≥ 18 years.
- •Diagnosed with atrial fibrillation (AF), including paroxysmal AF (PAF) and persistent AF (PsAF).
- •Scheduled to undergo first-time catheter ablation for AF.
- •Procedure to be performed using a 3D mapping system.
- •Provision of signed written informed consent for study participation and willingness and ability to comply with all protocol-required follow-up assessments.
排除标准
- •(Patients meeting ANY of the following criteria will be excluded):
- •Severe congenital heart disease (e.g., Tetralogy of Fallot, corrected transposition of the great arteries).
- •AF secondary to a clearly reversible cause (e.g., hyperthyroidism, post-operative state, acute alcohol intoxication).
- •Unstable angina pectoris or acute myocardial infarction (MI) within 30 days prior to enrollment/procedure.
- •Severe active infection (e.g., septic shock, sepsis).
- •Contraindications to anticoagulation therapy.
- •Current participation in another interventional clinical trial that may confound the results of this study.
- •Any other condition where, in the investigator's judgment, the patient is unsuitable for participation in this study.
- •Ventricular Tachycardia (VT) Cohort
- •Inclusion Criteria (Patients must meet ALL of the following criteria):
- •Age ≥ 18 years.
- •Diagnosed with ventricular tachycardia (VT) associated with underlying structural heart disease, including:
- •Ischemic heart disease (e.g., prior MI, coronary artery disease).
- •Non-ischemic cardiomyopathy (e.g., dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy (HCM)).
- •Scheduled to undergo first-time catheter ablation for VT.
- •Procedure to be performed using a 3D mapping system.
- •Provision of signed written informed consent for study participation and willingness and ability to comply with all protocol-required follow-up assessments.
- •Exclusion Criteria (Patients meeting ANY of the following criteria will be excluded):
- •VT due to a transient or reversible cause (e.g., acute myocardial ischemia, severe electrolyte imbalance).
- •Idiopathic ventricular tachycardia (VT occurring in the absence of structural heart disease).
- •Cardiac surgery within 60 days prior to the planned ablation procedure.
- •Severe coagulopathy (e.g., platelet count < 50 x 10⁹/L, disseminated intravascular coagulation (DIC)).
- •Severe heart failure with left ventricular ejection fraction (LVEF) < 20%.
- •Severe active infection (e.g., septic shock, sepsis).
- •Current participation in another interventional clinical trial that may confound the results of this study.
- •Any other condition where, in the investigator's judgment, the patient is unsuitable for participation in this study.
结局指标
主要结局
Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure
时间窗: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 12-month follow-up
时间窗: 12 months
Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia \>30 seconds. Cardiovascular rehospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 12-month follow-up.
次要结局
未报告次要终点