Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation (COR Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of patients without AF recurrences longer than 2 minutes
研究概览
简要总结
This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter versus the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.
详细描述
Pulmonary vein (PV) isolation using a radiofrequency catheter is the most widespread technique for atrial fibrillation (AF) ablation. These procedures are difficult and time-consuming, because they require precise catheter manipulation and multiple radiofrequency applications. Thus, alternative techniques are being investigated to simplify the procedure. Recently, a cryoenergy balloon catheter has been developed for PV isolation (Arctic Front®, Cryocath Technologies). When this catheter is deployed at the PV antrum, it can create a circumferential lesion around the PV ostium by delivering a single cryoenergy application.
An implantable loop recorder for AF detection has been made available (Reveal XT®, Medtronic). It may help taking clinical decisions regarding anticoagulant and antiarrhythmic therapy and, at the same time, it may be a powerful tool to evaluate the efficacy of different therapeutic strategies.
This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter vs. the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic recurrent paroxysmal AF (>2 episodes in the last 6 months), and
- •Refractory to one or more class I or III antiarrhythmic drugs, and
- •PV anatomy consisting of 4 single PV, with the long diameter of the right superior PV ostium ≤ 20 mm.
排除标准
- •Age: < 18 or > 75 year-old
- •Prior AF ablation
- •Pregnancy
- •Concomitant acute illness
- •Hyperthyroidism
- •Moderate to severe valvular heart disease
- •Prior cardiac surgery
- •Left atrium > 50 mm (anteroposterior diameter, parasternal long-axis view)
- •Intracardiac thrombus
- •Contraindications for anticoagulant therapy
- •Inability to be followed in our center for at least 1 year
结局指标
主要结局
Proportion of patients without AF recurrences longer than 2 minutes
时间窗: At the 12th month from ablation (using a blanking period of 3 months following ablation)
次要结局
- Proportion of pulmonary veins remaining isolated(At the end of the ablation procedure)
- Time to first AF recurrence longer than 2 minutes(Within the first 12 months from ablation (using a blanking period of 3 months following ablation, and without the use of any blanking period))
- Cumulative burden of AF (number of AF episodes longer than 2 minutes)(At the 12th month from ablation (using a blanking period of 3 months following ablation))
- Cumulative burden of AF (percentage of time in AF)(At the 12th month from ablation (using a blanking period of 3 months following ablation))
- Proportion of patients with episodes of regular atrial tachycardia or atrial flutter requiring treatment with drugs, electrical cardioversion or ablation.(Within the first 12 months from ablation)
- Quality of Life and symptom status(At the 12th month from ablation)
- Proportion of patients with procedure-related complications(Within the first 12 months from ablation)
- Procedure time (minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter)(At the end of the ablation procedure)
- Ablation time (minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery).(At the end of the ablation procedure)
- Fluoroscopy time (minutes of fluoroscopy used during the entire ablation procedure)(At the end of the ablation procedure)
研究者
Nicasio Perez Castellano
MD, PhD
Hospital San Carlos, Madrid