Catheter Ablation for Cure of Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 129
- 主要终点
- Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).
研究概览
简要总结
The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating additional lines of block with the aid of the NAVISTAR® THERMOCOOL® catheter in conjunction with the CARTO™ EP Navigation System. Effectiveness will be determined by comparing the chronic success of ablation therapy versus antiarrhythmic drug therapy, defined as the absence of persistent tachyarrhythmias during the first 24 months after a run-in phase of 2 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years
- •Written informed consent
- •One documented relapse of atrial fibrillation (AF) during antiarrhythmic drug therapy after an electrical cardioversion
排除标准
- •Permanent atrial fibrillation
- •Patients who had tried >1 antiarrhythmic drug (Class I or Class III).
- •AF was the sole rhythm for >6 months before the enrollment.
- •Previous ablation for AF.
- •AF is deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy.
- •Patients who have fibrillation episodes triggered by another uniform arrhythmia (eg, atrial flutter or atrial tachycardia).
- •Patients with intra-atrial thrombus, tumor, or another abnormality that precludes catheter introduction.
- •Patients with Wolf-Parkinson-White syndrome.
- •Patients awaiting cardiac transplantation.
- •Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-III-IV or ejection fraction (EF) <40%.
- •Patients with unstable angina or acute myocardial infarction within 3 months.
- •Patients with cardiac revascularization or other cardiac surgery within 6 months.
- •Patients with heart disease in which corrective surgery is anticipated.
- •Patients in whom appropriate vascular access is precluded.
- •Pregnant women.
- •A separate requirement for antiarrhythmic drug treatment, which will require an antiarrhythmic drug not previously tried for AF suppression.
- •Prior atrial surgery.
- •Contraindication to treatment with warfarin or other bleeding diathesis.
- •Renal failure requiring dialysis.
- •Hepatic failure.
- •Participant in investigational clinical or device trial.
- •Unwilling or unable to give informed consent.
- •Inaccessible for follow-up.
- •Psychological problem that might limit compliance.
- •Active abuse of alcohol or other drugs which may be causative of AF.
- •An implanted device (pacemaker or cardioverter-defibrillator).
- •Left atrial diameter (anteroposterior) >50 mm.
研究组 & 干预措施
1
Catheter ablation
干预措施: RF ablation (Device)
2
Antiarrhythmic drugs
干预措施: Antiarrhythmic drugs (Drug)
结局指标
主要结局
Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).
时间窗: within first 24 months after a 2-month run-in phase
Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions.
次要结局
- Quality of Life(at 14, 26 and 38 months)
- Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase(day 61 through 790)
- Health-economics Parameters (Days of Hospitalization)(at 26 months and at each patients last follow-up visit)
- Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor(at each patients last follow-up visit)
- Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months)(within first 24 months after a 2-month run-in phase)
- Percentage of Procedural Success(The day of the procedure)
- Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs(at 26 months and at each patients last follow-up visit)