Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation (The PLEA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 124
- 试验地点
- 26
- 主要终点
- A composite of thromboembolic events, myocardial perforation, pulmonary vein stenosis, atrioesophageal fistula, left and right phrenic nerve paralysis, and other serious adverse events within 12 months post-procedure.
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of empirical posterior wall isolation (PWI), left atrial appendage electrical isolation (LAAEI) and coronary sinus isolation (CSI) when compared to pulmonary vein isolation (PVI) alone:
- PVI alone,
- PVI + PWI,
- PVI + PWI + LAAEI,
- PVI + PWI + LAAEI + CSI.
详细描述
The Posterior Wall and/or Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation (The PLEA Trial) is a prospective multicenter randomized controlled study that has the overall goal of establishing the efficacy and safety of different ablation techniques for patients with persistent and long-standing persistent atrial fibrillation. The PLEA trial is designed to test the hypothesis whether posterior wall isolation (PWI) with pulmonary vein isolation (PVI), PWI plus left atrial appendage electrical isolation (LAAEI) with PVI and PWI plus LAAEI plus coronary sinus isolation (CSI) with PVI is superior to the standard approach alone (i.e. PVI alone) in decreasing the incidence of the composite endpoint of all-cause mortality and all-atrial arrhythmia recurrences.
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, Outcomes Assessor)
盲法说明
The nature of the ablation procedures precludes blinding of physicians to patient treatment. However, patients will be blinded to their ablation strategy (single-blind design) and endpoint assessment will be made by blinded adjudicators from an independent core laboratory.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 or greater
- •In good general health as evidenced by medical history and diagnosed with symptomatic persistent AF or long-standing persistent AF.
- •Persistent AF will be defined as a sustained episode lasting > 7 days and less than 1 year.
- •Long-standing persistent AF will be defined as a sustained episode lasting more than 1 year and less than 10 years.
- •Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
- •At least one episode of persistent AF must have been documented by ECG, Holter, loop recorder, ziopatch, telemetry, trans telephonic monitoring (TTM), or implantable device within last 10 years of enrollment in this investigation.
- •Patients undergoing first time procedure for AF.
排除标准
- •Patients with paroxysmal AF.
- •Paroxysmal AF will be defined as a sustained episode lasting < 7 days (either terminated spontaneously or with pharmacological or electrical cardioversion.
- •Reversible causes of AF.
- •Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors.
- •Patients with left atrial size ≥ 75 mm (2D echocardiography, parasternal long axis view)
- •Left atrial or LAA thrombus
- •Patients with severe valvular heart disease or after mitral valve replacement (bioprosthetic or mechanical).
- •Patients with a life expectancy ≤ 24 months
- •CHA2DS2Vasc score of 0 for men and CHA2DS2Vasc score of 1 for women.
- •Patients who are pregnant.
结局指标
主要结局
A composite of thromboembolic events, myocardial perforation, pulmonary vein stenosis, atrioesophageal fistula, left and right phrenic nerve paralysis, and other serious adverse events within 12 months post-procedure.
时间窗: 12 months
The primary safety endpoint is defined as a composite of thromboembolic events, myocardial perforation, pulmonary vein stenosis, atrioesophageal fistula, left and right phrenic nerve paralysis, and other serious adverse events within 12 months post-procedure.
Freedom from documented AF/AT/AFL episodes and all-cause mortality after initial procedure
时间窗: 12 months
The primary effectiveness endpoint is defined as the freedom from documented AF/AT/AFL episodes (\> 30 seconds) and all-cause mortality within 12 months after one ablation procedure without antiarrhythmic medications after blanking period (3 months after ablation) as adjudicated by the independent Core Laboratory. Atrial Fibrillation (AF) Atrial Tachycardia (AT) Atrial Flutter (AFL)
次要结局
- Procedure duration and fluoroscopy time(Day of Procedure)
- Incidence of peri-procedural and 12-month post procedural complications.(12, 24 and 60 months)
- All-cause mortality(12, 24 and 60 months)
- Cardiovascular hospitalizations(12, 24 and 60 months)
- Number of repeat procedures(12 months)
- Long-term follow-up at 24 and 60 months to evaluate freedom of documented AF/AT/AFL episodes (>30 seconds) and all-cause mortality adjudicated by the Core Laboratory(24 and 60 months)
- Heart failure analysis(12, 24 and 60 months)
- Cost-effectiveness analysis(12 months)
- Freedom from documented AF/AT/AFL episodes (>30 seconds) and all-cause mortality within 12 months after redo ablation procedure.(12 months)
- AF/AT/AFL Burden(12, 24 and 60 months)
- Atrial contractility(6 months)