X-TRA CLINICAL TRIAL (X-therapy for Redo AF Ablation). Strategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 10
- 主要终点
- Compare the effectiveness of the technique crossover strategy versus the repetition of the same technique for the isolation of the pulmonary veins during a second ablation procedure indicated by recurrence of AF
研究概览
简要总结
Randomized phase III clinical trial to compare the efficacy of the two most widely used ablation techniques (cryotherapy and radiofrequency) after recurrence of atrial fibrillation (AF) in patients requiring a new ablation procedure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal FA (one that ends, spontaneously or not, within 7 days of its onset. GUIDELINES ESC FA 2020)
- •Have undergone an initial AF ablation procedure using Cryoballoon or point-to-point focal RF within the three years prior to the initial visit.
- •During the initial AF ablation procedure ONLY pulmonary vein isolation / ablation will have been performed
- •Documented recurrence of AF lasting more than 30 seconds after the first ablation procedure.
- •With the ability and willingness to sign the informed consent of the patient.
- •With a minimum follow-up capacity of 12 months.
排除标准
- •Patients aged <18 years.
- •Previous heart surgery.
- •Moderate or severe mitral valve disease.
- •Severe dilation of the left atrium, defined as a volume greater than 48 ml / m2 or a left atrial diameter greater than 50 mm in the parasternal long axis.
- •Contraindication for anticoagulation.
- •Pregnancy or pregnancy intention during the 12-month follow-up.
- •Life expectancy less than 12 months.
- •Unavailability for follow-up for 12 months.
- •Simultaneous participation in another clinical trial
研究组 & 干预措施
Cross-over of ablation technique
Cross-over of cardiac ablation procedures (cryotherapy and radiofrequency; radiofrequency and cryotherapy)
干预措施: Ablation (Procedure)
Repetition of the same technique
Repeat the same procedure (cryotherapy and cryotherapy; radiofrequency and radiofrequency)
结局指标
主要结局
Compare the effectiveness of the technique crossover strategy versus the repetition of the same technique for the isolation of the pulmonary veins during a second ablation procedure indicated by recurrence of AF
时间窗: 42 months
The rate of recurrent AF will be documented to check whether it is better to cross ablation techniques or not. This efficacy is defined as the absence of documented AF recurrence lasting more than 30 seconds, during a 12-month follow-up after the second ablation procedure.
次要结局
- To compare the efficacy of the AF re-ablation procedure based on the initial technique and the technique of the second procedure, during a 12-month follow-up after the second ablation procedure.(42 months)
- Analyze potential predictors of efficacy of each of the techniques based on the anatomy of the left atrium and pulmonary veins. Evaluate the number of reconnected pulmonary veins through cardiac imaging procedures(42 months)