Modified Stepwise Ablation Guided by Low Dose Ibutilide in Chronic Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Number of Participants With 1 Year Freedom From AF / AT
研究概览
简要总结
Procedures for ablation of persistent or long lasting atrial fibrillation are frequently long and require extensive ablation. Some electrophysiologists administer the drug ibutilide during these procedures to help organize the fibrillatory activity of the left atrium with the hope that this may shorten the length of the procedure and duration of ablation needed. Currently there is no standardized approach of administering the drug ibutilide during these procedures, thus the investigators cannot be certain that administering this drug does in fact facilitate the procedure. The aim of the MAGIC-AF Trial is to see if administering a standard dose of the drug ibutilide at a standard time in the procedure can allow for a reduction in the ablation procedure time. The investigators hypothesize that administering ibutilide during these procedures will result in a reduction in the procedure and ablation time required.
详细描述
Definition: Patients with persistent atrial fibrillation will be enrolled in this trial. All patients will be required to be in atrial fibrillation on the day of the procedure. Standard pulmonary vein (PV) isolation will be performed. Patients will be enrolled in the trial if they remain in atrial fibrillation after bi-directional block is obtained in the left and right sided PVs. At this point, patients will be randomized to receive 0.25mg of IV ibutilide or a placebo (normal saline). Patients will then undergo additional ablation with areas of complex fractionate electrograms (CFE) being targeted. The duration of additional CFE ablation and use of additional non-PV ablation (i.e. placement of linear lesions) will be left to the discretion of the operator. Patients will be followed for 1 year. The primary outcome assessed will be freedom from AF at 1 year.
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)
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
- •Males and females will be enrolled in the study.
- •Referred for a first ever ablation procedure for symptomatic persistent/permanent AF (only prior ablation of right-sided typical flutter is permitted)
- •All patients must understand the requirements of the study and be willing to comply with the post study follow-up requirements.
- •Patients must be in atrial fibrillation on the day of the procedure
排除标准
- •Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
- •Patients with a myocardial infarction or unstable angina in the previous 2 months.
- •Patients with a history of rheumatic heart disease
- •Patients with congenital heart disease
- •Patients with a history of hypertrophic cardiomyopathy
- •Patients with LV ejection fraction < 35%
- •Class IV congestive heart failure
- •Patients who have experienced any cerebral ischemic event, including any TIA in the preceding 1 month.
- •Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure.
- •Patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).
- •Patients whose life expectancy is less than one year.
- •History of malignant ventricular arrhythmias or long QT interval (>500msec)
- •Prior left-sided cardiac ablation procedure (catheter based or surgical)
- •Mental impairment precluding the patient from providing informed consent or completing the appropriate follow up
研究组 & 干预措施
Ibutilide arm
干预措施: Ibutilide (Drug)
Placebo arm
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With 1 Year Freedom From AF / AT
时间窗: one year
Freedom from atrial arrhythmia after repeat procedures with or without drugs
次要结局
- Radiofrequency Ablation Time(at time of the procedure)
- Procedure Time(at time of the procedure)
- AF Termination(at time of the procedure)
研究者
Vivek Reddy
Director Cardiac Arrhythmia Service, Professor Of Medicine
Icahn School of Medicine at Mount Sinai