Linear Ablation Added to Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone Using Pulsed Field Ablation for Persistent Atrial Fibrillation: a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Primary Effectiveness Endpoint with Treatment Success.
研究概览
简要总结
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)
详细描述
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to PVI outperforms PVI alone using PFA in maintaining sinus rhythm for PerAF. Enrolled subjects will be randomized by the ratio of 1:1 into PVI and linear ablation arm or PVI alone arm. Subjects in PVI and linear ablation arm will undergo bilateral PVI, and linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device and EIVOM could be performed additionally before or after PFA at the operator's discretion, it is recommended to perform EIVOM first. Subjects randomized to the PVI alone arm will undergo PVI only. If atrial fibrillation (AF) cannot be terminated during ablation, cardioversion will be performed. After ablation, all the subjects will be followed at discharge, 1 month and then at 3-month intervals up to 12 months.
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
- Double (Participant, Investigator)
盲法说明
The control group will consist of subjects randomized into PVI alone arm, who will accept bilateral PVI only with the same study device as those used in the Test group.
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
- •Study subjects are required to meet all the following inclusion criteria:
- •Subjects with an age range of 18 years or above and 80 years or below.
- •Subjects have symptomatic, drug-resistant, persistent AF, defined as:
- •Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath.
- •Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD.
- •Persistent: continuous AF for > 90 days, i) with a minimum a physician's note confirming the diagnosis AND,within 180 days of Enrollment Date, either a 24-hour or longer continuous ECG recording confirming continuous AF OR Two ECGs showing continuous AF taken at least 90 days apart.
- •Subjects undergoing a first-time ablation procedure for AF.
- •Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.
排除标准
- •AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
- •Left atrial anteroposterior diameter ≥ 6.0 cm by transthoracic echocardiography (TTE) within 3 months prior the procedure.
- •Heart failure with left ventricular ejection fraction (LVEF) < 30% by TTE within 3 months prior the procedure.
- •LA thrombus detected by Transesophageal Echocardiography (TEE) or cardiac CT within one day before the procedure or Intracardiac Echocardiography (ICE) before atrial septal puncture during the procedure.
- •Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, mechanical valve, interatrial baffle, closure device, patch, or patent foramen oval occlude, left atrial appendage closure at the time of ablation.
- •Any of the following events within 90 days of the Consent Date:
- •Myocardial infarction, unstable angina or coronary intervention or any cardiac surgery
- •Pericarditis or symptomatic pericardial effusion
- •Gastrointestinal bleeding
- •Stroke, transient ischemic attack (TIA), or intracranial bleeding or any non-neurologic thromboembolic event
- •Contraindication to, or unwillingness to use systemic anticoagulation.
- •Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia.
- •Women of childbearing potential who are pregnant or lactating.
- •Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL/min/1.73 m2, or with any history of renal dialysis or renal transplant.
- •Conditions that in the investigator's medical opinion would interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.
- •Predicted life expectancy less than 12 months.
研究组 & 干预措施
PVI and linear ablation arm
Subjects in PVI and linear ablation arm will undergo bilateral PVI, and linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device, and EIVOM could be performed additionally before or after PFA at the operator's discretion.
干预措施: Linear ablation (Procedure)
PVI and linear ablation arm
Subjects in PVI and linear ablation arm will undergo bilateral PVI, and linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device, and EIVOM could be performed additionally before or after PFA at the operator's discretion.
干预措施: PVI alone (Procedure)
PVI alone arm
Subjects randomized to the PVI alone arm will undergo PVI only with the study device.
干预措施: PVI alone (Procedure)
结局指标
主要结局
Primary Effectiveness Endpoint with Treatment Success.
时间窗: Completion of treatment 360 days compared with the baseline
Number of Participants free from Arrhythmia, Re-ablation, Cardioversion, and AAD use.
Primary Safety Endpoint with Safety events related to AF catheter ablation.
时间窗: Completion of treatment 360 days compared with the baseline
Number of Participants with following device or procedure-related serious Composite Adverse Events (CAEs).
次要结局
- Secondary Effectiveness Endpoint with Chronic Success.(Completion of treatment 360 days compared with the baseline.)
- Secondary Safety Endpoint with Non-SAE.(Completion of treatment 360 days compared with the baseline)