Cryoballon Versus Conventional Radiofrequency Ablation for Persistent Atrial Fibrillation With AF Duration < 2 Years: the IRON-ICE Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 303
- 试验地点
- 3
- 主要终点
- Freedom from atrial tachycardia/fibrillation
研究概览
简要总结
A randomized trial has recently demonstrated non-inferiority of cryoballoon vs. radiofrequency (RF) catheter ablation in patients with drug-refractory paroxysmal atrial fibrillation (AF). There is a growing amount of evidence suggesting that Cryoballoon ablation is highly effective also in non-paroxysmal atrial fibrillation.
The IRON-ICE trial will evaluate the effect of Cryoballoon AF ablation in patients with short-term persistent 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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
- •Patients presenting with Persistent AF with AF duration < 2 years scheduled to undergo a PVAI procedure
- •Age range of 18 - 85 years
- •Patients with already implanted devices with AF detection capabilities (for clinical indications): ILR implanted in the same hospital stay or within 6 months before the ablation or patients with an dual chamber PM, ICD or CRTD and an existing functional atrial lead.
- •Patients must be able and willing to provide written informed consent to participate in the clinical trial.
排除标准
- •Congenital heart disease, age younger than 18 years, significant valve disease, LA size >55 mm, and severe heart failure (ejection fraction < 30% and/or New York Heart Association class IV).
- •Presence of a mechanical prosthetic valve.
- •Secondary causes of atrial fibrillation
- •Documented intra-atrial thrombus or another abnormality which precludes catheter introduction.
- •Social factors that would preclude follow up or make compliance difficult.-
- •Patients who are or may potentially be pregnant Previous left atrial catheter ablation or MAZE procedure.
研究组 & 干预措施
Cryoballoon ablation
Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line.
干预措施: Cryoballoon ablation (Procedure)
Radiofrequency Ablation
Contact force-sensing radiofrequency left atrial ablation with 3D mapping system.
干预措施: Radiofrequency Ablation (Procedure)
结局指标
主要结局
Freedom from atrial tachycardia/fibrillation
时间窗: 12 months
Freedom from atrial tachycardia/fibrillation within 12 months after CA. Arrhythmias had to last 30 seconds or more to be considered present.
次要结局
- Length of postoperative hospital stay.(1 month)
- Total procedural time.(1 day)
- Significant reduction in AF burden(12 months)
- Number of AF episodes recorded.(12 months)
- Left atrial instrumentation time(1 day)
- Incidence of cerebrovascular events from the time of the operation up to 90 days.(90 Days)
- Death from any cause(12 months)
- Low daily AF burden(12 months)
- Duration of AF episodes recorded.(12 months)
- Fluoroscopy time(1 day)
- Procedure-related complications(1 week)
- Long-term success(36 months)
- Hospitalizations after discharge.(12 months)
- Freedom from persistent AF/AFL/AT (duration cutoff of 7 days)(12 months)
- Freedom from clinical or stroke-relevant AF/AFL/AT.(12 months)
- Regression from persistent to non-paroxysmal atrial fibrillation(12 months)
研究者
Giovanni B Forleo
Section Head Electrophysiology and Cardiac Pacing.
Luigi Sacco University Hospital