First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment: A Multi-center Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 16
- 主要终点
- Number of Participants With Recurrence of Atrial Tachyarrhythmia
研究概览
简要总结
The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs.
详细描述
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and is estimated to affect 2.2 million people in the United States. AF is a major cause of stroke, adversely affects quality of life, and is associated with increased mortality. Despite advances in antiarrhythmic drug therapy, AF continues to be associated with significant morbidity. Although antiarrhythmic drug therapy is currently considered a first-line option, recent data indicate that more than 35% of Patients will have recurrence of AF despite best antiarrhythmic drug (AAD) therapy, and more than 30% of Patients will discontinue the drugs because of adverse reactions. Furthermore, although recent trials have indicated equivalence of rhythm and rate control strategies in some patient populations, 25-35% of Patients with AF who are rate controlled will continue to have activity limiting symptoms. Newer measures to prevent, treat and potentially cure AF are needed. Seminal work by Haissaguerre and replicated by Chen showed that the majority of AF is initiated by ectopic foci found primarily in the pulmonary veins (PV). Experience with the catheter-based Maze technique led to observations that opened the door to effective and practical catheter-based cures for AF. In response to the difficulties of focal ablation, an alternate strategy has been developed that seeks to electrically isolate the Pulmonary Veins from the atrial tissue. Empirical PV isolation targets all of the PV's without regard to the initiation of ectopic beats. The goal is to create entrance block in the PV. Multipolar circular catheters and basket catheters have been developed that facilitate identification of the electrical connections that are present at the junction of the atrium and the PV, and radiofrequency energy is applied in a circumferential fashion until entrance block is achieved. Relative to focal ablation, circumferential PV isolation is simpler to perform, can be completed without inducing AF, has a shorter procedure time, and has a lower incidence of PV stenosis.
Comparison: Patients will have ablation to achieve entrance and/or exit block into all pulmonary veins, compared with patients receiving antiarrhythmic drugs given in accordance with ACC/AHA/ESC 2006 Guidelines for the Management of patients with AF.
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
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and ≤ 75 years old.
- •Symptomatic, recurrent paroxysmal AF lasting > 30 seconds (at least 4 episodes within the prior 6 months). At least one episode must be documented by Holter,12-lead ECG, event monitor or rhythm strip.
排除标准
- •Documented LVEF <40%.
- •Documented left atrial diameter >5.5cm.
- •Moderate to severe LVH (LV wall thickness >1.5cm).
- •Documented valvular disease, coronary heart disease (defined as the presence of >70% stenosis of coronary arteries or documentation of active myocardial ischemia), post-CABG, postoperative cardiac surgery or peripheral artery disease.
- •Documented AF with electrical cardioversion where full therapeutic antiarrhythmic drug therapy after the cardioversion was prescribed.
- •Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
- •Contraindication for the use of sotalol, dofetilide and 1C antiarrhythmic drugs(liver enzymes and serum creatinine that are outside the upper normal lab values, e.g. > 3 times ULN with 2 abnormal lab values).
- •Previous left heart ablation procedure, either by surgery or by percutaneous catheter, for atrial fibrillation.
- •Current enrollment in another investigational drug or device study.
- •Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the Patient for the entire study period.
- •Absolute contra-indication to the use of heparin and or warfarin.
- •Increase risk of bleeding, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding, or other history of bleeding diathesis or coagulopathy.
- •Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD).
- •Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction.
- •Previous use of full therapeutic dose of an antiarrhythmic drug, including amiodarone, propafenone, flecainide, sotalol, quinidine.
- •Pacemaker or Implantable Cardioverter Defibrillator.
- •Women with a positive pregnancy test.
- •Evidence of active cardiac or systemic infection.
- •Medical condition limiting expected survival to less than one year.
研究组 & 干预措施
Catheter Ablation
Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation
干预措施: Pulmonary Vein Isolation performed by Catheter Ablation (Procedure)
Antiarrhythmic Drug Therapy
Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation
干预措施: Conventional Antiarrhythmic Drug Therapy (Drug)
结局指标
主要结局
Number of Participants With Recurrence of Atrial Tachyarrhythmia
时间窗: Assessed during 21 month follow-up period
Recurrence of electrocardiographically documented atrial fibrillation, atrial flutter or atrial tachycardia lasting \>30 seconds during Follow-up Period. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).
Comparison of Proportion of Patients With an Occurrence of Any of a Cluster of Serious Complications in Either Arm
时间窗: Assessed during entire 24 month study period
Ablation arm cluster: death, cardiac tamponade, severe PV stenosis\>70%, atrioesophageal fistula, thromboembolism, vascular complications (i.e. arterial pseudoaneurysm, arteriovenous fistula and hematoma leading to transfusion), phrenic nerve injury or complete AV block requiring permanent pacemaker implantation. Antiarrhythmic drug arm cluster: Death, torsade de pointes, bradycardia leading to pacemaker insertion, syncope, QRS duration prolongation \> 50% of baseline, 1:1 atrial flutter or any other significant adverse events that leads to drug discontinuation.
次要结局
- Number of Participants With Recurrence of Symptomatic Atrial Tachyarrhythmia(21 months of follow-up)
- Quality of Life EQ5D Index Score(Measured at 12 months after randomization)
- Number of Participants With Recurrence of Symptomatic Atrial Fibrillation(During 21 month follow-up period)
- Episodes of ANY Recurrence of Atrial Tachyarrhythmia(During 21 month follow-up period)
- Number of Participants With Recurrence of Atrial Tachyarrhythmia Obtained Clinically(During 21 month follow-up period)
- Quality of Life EQ-5D Visual Analog Score(Measured At 12 months after randomization)